Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03491553
• Collaborator: (none)
• Enrollment: 48
• Locations: 2
• Arms: 6
• Actual Duration (Months): 28.2
• Patients Per Site: 24
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Selgantolimod; Drug: Placebo; Drug: Hepatitis B virus (HBV) OAV Therapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B
• Actual Study Start Date: Apr 6, 2018
• Actual Primary Completion Date: Mar 22, 2019
• Actual Study Completion Date: Aug 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selgantolimod 3 mg: HBeAg-positive CHB Participants Participants with Hepatitis B e Antigen (HBeAg)-positive CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Drug: Selgantolimod; Tablet(s) administered orally once weekly; Other Names: GS-9688 ; Drug: Hepatitis B virus (HBV) OAV Therapy; Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Experimental: Selgantolimod 3 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Drug: Selgantolimod; Tablet(s) administered orally once weekly; Other Names: GS-9688 ; Drug: Hepatitis B virus (HBV) OAV Therapy; Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Experimental: Selgantolimod 1.5 mg: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Drug: Selgantolimod; Tablet(s) administered orally once weekly; Other Names: GS-9688 ; Drug: Placebo; Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly; Drug: Hepatitis B virus (HBV) OAV Therapy; Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Experimental: Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Drug: Selgantolimod; Tablet(s) administered orally once weekly; Other Names: GS-9688 ; Drug: Placebo; Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly; Drug: Hepatitis B virus (HBV) OAV Therapy; Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Experimental: Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Drug: Placebo; Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly; Drug: Hepatitis B virus (HBV) OAV Therapy; Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Experimental: Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.	Drug: Placebo; Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly; Drug: Hepatitis B virus (HBV) OAV Therapy; Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 [Week 24]

Secondary Outcome Measures

1. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4 [Week 4]

2. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8 [Week 8]

3. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12 [Week 12]

4. Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48 [Week 48]

5. Change From Baseline in Serum qHBsAg at Week 4 [Baseline, Week 4]

6. Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8 [Baseline, Week 8]

7. Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12 [Baseline, Week 12]

8. Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24 [Baseline, Week 24]

9. Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48 [Baseline, Week 48]

10. Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 [Week 12]

    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

11. Percentage of Participants With HBsAg Loss at Week 24 [Week 24]

    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

12. Percentage of Participants With HBsAg Loss at Week 48 [Week 48]

    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

13. Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 [Week 12]

    HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

14. Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 [Week 24]

    HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

15. Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 [Week 48]

    HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit.

16. Percentage of Participants With Virologic Breakthrough [Baseline up to Week 48]

    Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL.

17. Percentage of Participants With Drug Resistance Mutations [Baseline up to Week 48]

    The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

• Adult males and non-pregnant, non-lactating females

• Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels

• On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening

• HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening

• Screening Electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

• Extensive bridging fibrosis or cirrhosis

• Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:

• Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)

• International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen

• Albumin < 3.5 g/dL

• Direct bilirubin > 1.5x ULN

• Platelet Count < 100,000/uL

• Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)

• Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus

• Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging

• Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.

• Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease

• Received solid organ or bone marrow transplant

• Received prolonged therapy with immunomodulators or biologics within 3 months of screening

• Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, Institute of Human Virology	Baltimore	Maryland	United States	21201
2	Auckland Clinical Studies Limited	Auckland		New Zealand	1010

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

• Study Protocol - Aug 27, 2019
• Statistical Analysis Plan: Week 24 Analysis and Final Analysis - Jan 18, 2019
• Statistical Analysis Plan: TFFU (Treatment-Free Follow-Up) Analysis - Sep 11, 2020

More Information

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT03491553
• Other Study ID Numbers: GS-US-389-2024; ACTRN12618000143224p
• First Posted: Apr 9, 2018
• Last Update Posted: Aug 19, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at study sites in New Zealand and the United States. The first participant was screened on 6 April 2018. The last study visit occurred on 10 August 2020.
Pre-assignment Detail	59 participants were screened.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) remained on their current oral antiviral (OAV) and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants could continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
Period Title: Main Study (Up to Week 48)
STARTED	9	10	10	10	5	4
COMPLETED	8	9	10	9	5	4
NOT COMPLETED	1	1	0	1	0	0
Period Title: Main Study (Up to Week 48)
STARTED	0	1	0	0	0	0
COMPLETED	0	1	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants	Total
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Total of all reporting groups
Overall Participants	9	10	10	10	5	4	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (7.8)	46 (10.1)	43 (5.6)	53 (6.8)	43 (7.9)	57 (10.5)	47 (8.9)
Sex: Female, Male (Count of Participants)
Female	2 22.2%	3 30%	3 30%	1 10%	1 20%	2 50%	12 25%
Male	7 77.8%	7 70%	7 70%	9 90%	4 80%	2 50%	36 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	9 100%	10 100%	10 100%	10 100%	5 100%	4 100%	48 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	5 55.6%	6 60%	5 50%	7 70%	3 60%	2 50%	28 58.3%
Black or African American	0 0%	3 30%	0 0%	1 10%	0 0%	1 25%	5 10.4%
Native Hawaiian or Pacific Islander	4 44.4%	1 10%	4 40%	1 10%	1 20%	1 25%	12 25%
White	0 0%	0 0%	1 10%	0 0%	0 0%	0 0%	1 2.1%
Other	0 0%	0 0%	0 0%	1 10%	1 20%	0 0%	2 4.2%
Region of Enrollment (Count of Participants)
United States	1 11.1%	7 70%	1 10%	6 60%	0 0%	2 50%	17 35.4%
New Zealand	8 88.9%	3 30%	9 90%	4 40%	5 100%	2 50%	31 64.6%
Hepatitis B Surface Antigen (HBsAg) (log10 IU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [log10 IU/mL]	3.4 (0.57)	2.6 (1.58)	3.4 (0.62)	1.7 (1.10)	3.3 (0.46)	3.2 (0.42)	2.9 (1.14)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

The Full Analysis Set included all randomized participants who took at least 1 dose of the study drug.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	10.0 100%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	10.0
	Confidence Interval	(2-Sided) 95%; -47.2 to 47.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.

2. Secondary Outcome

Title	Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	10.0 100%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 3 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants, Placebo: HBeAg-positive CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants, Placebo: HBeAg-negative CHB Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	10.0
	Confidence Interval	(2-Sided) 95%; -47.2 to 47.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.

6. Secondary Outcome

Title	Change From Baseline in Serum qHBsAg at Week 4
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	7	10	9	10	5	4
Mean (Standard Deviation) [log10 IU/mL]	0.02 (0.047)	-0.07 (0.110)	0.00 (0.070)	-0.01 (0.127)	-0.02 (0.034)	-0.03 (0.058)

7. Secondary Outcome

Title	Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	8	10	10	9	5	4
Mean (Standard Deviation) [log10 IU/mL]	0.00 (0.051)	-0.05 (0.117)	-0.01 (0.041)	-0.04 (0.119)	0.02 (0.041)	-0.03 (0.061)

8. Secondary Outcome

Title	Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	8	10	10	9	5	4
Mean (Standard Deviation) [log10 IU/mL]	-0.01 (0.059)	-0.05 (0.117)	0.00 (0.050)	-0.04 (0.115)	0.05 (0.034)	0.00 (0.048)

9. Secondary Outcome

Title	Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	8	7	8	9	5	4
Mean (Standard Deviation) [log10 IU/mL]	0.01 (0.059)	-0.05 (0.136)	-0.05 (0.059)	-0.16 (0.460)	-0.02 (0.048)	-0.01 (0.066)

10. Secondary Outcome

Title	Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	8	9	10	9	5	4
Mean (Standard Deviation) [log10 IU/mL]	-0.01 (0.073)	-0.05 (0.145)	-0.07 (0.110)	-0.17 (0.523)	0.00 (0.049)	-0.05 (0.050)

11. Secondary Outcome

Title	Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
Description	HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number [percentage of participants]	0 0%	10.0 100%	0 0%	0 0%	0 0%	0 0%

12. Secondary Outcome

Title	Percentage of Participants With HBsAg Loss at Week 24
Description	HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number [percentage of participants]	0 0%	10.0 100%	0 0%	0 0%	0 0%	0 0%

13. Secondary Outcome

Title	Percentage of Participants With HBsAg Loss at Week 48
Description	HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	10	10	5	4
Number [percentage of participants]	0 0%	10.0 100%	0 0%	10.0 100%	0 0%	0 0%

14. Secondary Outcome

Title	Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
Description	HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Placebo: HBeAg-positive CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	5
HBeAg Loss	0 0%	10.0 100%	0 0%
HBeAg Loss and Seroconversion	0 0%	0 0%	0 0%

15. Secondary Outcome

Title	Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Description	HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Placebo: HBeAg-positive CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	5
HBeAg Loss	0 0%	10.0 100%	0 0%
HBeAg Loss and Seroconversion	0 0%	0 0%	0 0%

16. Secondary Outcome

Title	Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Description	HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Placebo: HBeAg-positive CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	9	10	5
HBeAg Loss	22.2 246.7%	10.0 100%	0 0%
HBeAg Loss and Seroconversion	11.1 123.3%	0 0%	0 0%

17. Secondary Outcome

Title	Percentage of Participants With Virologic Breakthrough
Description	Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL.
Time Frame	Baseline up to Week 48

Outcome Measure Data

Analysis Population Description

There were no participants analyzed for the outcome measure since none of the participants met the criteria.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	0	0	0	0	0	0

18. Secondary Outcome

Title	Percentage of Participants With Drug Resistance Mutations
Description	The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL.
Time Frame	Baseline up to Week 48

Outcome Measure Data

Analysis Population Description

There were no participants analyzed for the outcome measure since none of the participants met the criteria.

Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants	Selgantolimod 3 mg: HBeAg-negative CHB Participants	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants	Placebo: HBeAg-positive CHB Participants	Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Measure Participants	0	0	0	0	0	0

Adverse Events

Time Frame	Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months
Adverse Event Reporting Description	Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Arm/Group Title	Selgantolimod 3 mg: HBeAg-positive CHB Participants		Selgantolimod 3 mg: HBeAg-negative CHB Participants		Selgantolimod 1.5 mg: HBeAg-positive CHB Participants		Selgantolimod 1.5 mg: HBeAg-negative CHB Participants		Placebo: HBeAg-positive CHB Participants		Placebo: HBeAg-negative CHB Participants
Arm/Group Description	Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.		Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.		Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.		Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.		Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.		Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
All Cause Mortality
	Selgantolimod 3 mg: HBeAg-positive CHB Participants		Selgantolimod 3 mg: HBeAg-negative CHB Participants		Selgantolimod 1.5 mg: HBeAg-positive CHB Participants		Selgantolimod 1.5 mg: HBeAg-negative CHB Participants		Placebo: HBeAg-positive CHB Participants		Placebo: HBeAg-negative CHB Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Serious Adverse Events
	Selgantolimod 3 mg: HBeAg-positive CHB Participants		Selgantolimod 3 mg: HBeAg-negative CHB Participants		Selgantolimod 1.5 mg: HBeAg-positive CHB Participants		Selgantolimod 1.5 mg: HBeAg-negative CHB Participants		Placebo: HBeAg-positive CHB Participants		Placebo: HBeAg-negative CHB Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		0/10 (0%)		1/10 (10%)		2/10 (20%)		0/5 (0%)		0/4 (0%)
Cardiac disorders
Atrial fibrillation	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Eye disorders
Iridocyclitis	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Gastrointestinal disorders
Abdominal pain lower	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Infections and infestations
Perineal abscess	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Selgantolimod 3 mg: HBeAg-positive CHB Participants		Selgantolimod 3 mg: HBeAg-negative CHB Participants		Selgantolimod 1.5 mg: HBeAg-positive CHB Participants		Selgantolimod 1.5 mg: HBeAg-negative CHB Participants		Placebo: HBeAg-positive CHB Participants		Placebo: HBeAg-negative CHB Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		10/10 (100%)		8/10 (80%)		10/10 (100%)		5/5 (100%)		4/4 (100%)
Cardiac disorders
Palpitations	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Ear and labyrinth disorders
Tinnitus	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Eye disorders
Borderline glaucoma	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Cataract nuclear	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Conjunctivitis allergic	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Dry eye	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		2/4 (50%)
Eyelids pruritus	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Meibomian gland dysfunction	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Optic disc disorder	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Photophobia	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Pinguecula	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Vision blurred	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Vitreous detachment	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Gastrointestinal disorders
Abdominal discomfort	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Abdominal distension	1/9 (11.1%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Abdominal pain	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Abdominal pain lower	0/9 (0%)		1/10 (10%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Abdominal pain upper	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Constipation	0/9 (0%)		0/10 (0%)		1/10 (10%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Diarrhoea	1/9 (11.1%)		1/10 (10%)		0/10 (0%)		3/10 (30%)		1/5 (20%)		0/4 (0%)
Gastrooesophageal reflux disease	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Nausea	6/9 (66.7%)		5/10 (50%)		3/10 (30%)		4/10 (40%)		0/5 (0%)		0/4 (0%)
Umbilical hernia	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Vomiting	2/9 (22.2%)		3/10 (30%)		3/10 (30%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
General disorders
Asthenia	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Catheter site bruise	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Chest pain	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Chills	2/9 (22.2%)		2/10 (20%)		0/10 (0%)		1/10 (10%)		1/5 (20%)		0/4 (0%)
Exercise tolerance decreased	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Fatigue	0/9 (0%)		5/10 (50%)		1/10 (10%)		2/10 (20%)		0/5 (0%)		1/4 (25%)
Feeling hot	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Malaise	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Medical device site dermatitis	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Peripheral swelling	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Thirst	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Infections and infestations
Cellulitis	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Herpes zoster	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		1/5 (20%)		0/4 (0%)
Laryngitis	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Lower respiratory tract infection	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Perineal abscess	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Sinusitis	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Upper respiratory tract infection	1/9 (11.1%)		3/10 (30%)		1/10 (10%)		4/10 (40%)		2/5 (40%)		1/4 (25%)
Viral upper respiratory tract infection	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Injury, poisoning and procedural complications
Citrate toxicity	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Contusion	1/9 (11.1%)		1/10 (10%)		1/10 (10%)		2/10 (20%)		1/5 (20%)		0/4 (0%)
Ligament sprain	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Muscle strain	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Skin laceration	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Investigations
Urine output increased	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Metabolism and nutrition disorders
Gout	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Hypokalaemia	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/9 (0%)		0/10 (0%)		2/10 (20%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Back pain	2/9 (22.2%)		2/10 (20%)		2/10 (20%)		0/10 (0%)		2/5 (40%)		0/4 (0%)
Flank pain	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Joint stiffness	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Limb discomfort	0/9 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Muscle fatigue	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Musculoskeletal pain	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		1/4 (25%)
Myalgia	3/9 (33.3%)		0/10 (0%)		0/10 (0%)		2/10 (20%)		0/5 (0%)		0/4 (0%)
Pain in jaw	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Nervous system disorders
Dizziness	2/9 (22.2%)		1/10 (10%)		0/10 (0%)		2/10 (20%)		1/5 (20%)		0/4 (0%)
Dizziness postural	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Headache	2/9 (22.2%)		1/10 (10%)		2/10 (20%)		3/10 (30%)		2/5 (40%)		2/4 (50%)
Hypoaesthesia	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		1/5 (20%)		0/4 (0%)
Lethargy	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Neuropathy peripheral	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Taste disorder	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Psychiatric disorders
Hypomania	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Insomnia	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Irritability	0/9 (0%)		0/10 (0%)		1/10 (10%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Libido decreased	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Renal and urinary disorders
Nocturia	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Reproductive system and breast disorders
Amenorrhoea	0/9 (0%)		0/10 (0%)		1/10 (10%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Dysmenorrhoea	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Menorrhagia	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Pelvic pain	0/9 (0%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/9 (0%)		0/10 (0%)		2/10 (20%)		2/10 (20%)		1/5 (20%)		0/4 (0%)
Dyspnoea	2/9 (22.2%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Epistaxis	0/9 (0%)		1/10 (10%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Lower respiratory tract congestion	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Nasal congestion	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		1/5 (20%)		0/4 (0%)
Oropharyngeal pain	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Productive cough	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Throat irritation	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Upper-airway cough syndrome	0/9 (0%)		0/10 (0%)		1/10 (10%)		0/10 (0%)		0/5 (0%)		0/4 (0%)
Skin and subcutaneous tissue disorders
Pruritus	0/9 (0%)		1/10 (10%)		1/10 (10%)		2/10 (20%)		1/5 (20%)		0/4 (0%)
Rash	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Rash pruritic	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Skin mass	1/9 (11.1%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)
Vascular disorders
Haematoma	0/9 (0%)		0/10 (0%)		0/10 (0%)		1/10 (10%)		0/5 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years