Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01756898
• Collaborator: (none)
• Enrollment: 370
• Locations: 40
• Arms: 4
• Actual Duration (Months): 13.5
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: 5 mg ASB17061; Drug: Placebo; Drug: 10 mg ASB17061; Drug: 20 mg ASB17061	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 370 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
• Actual Study Start Date: Nov 28, 2012
• Actual Primary Completion Date: Jan 14, 2014
• Actual Study Completion Date: Jan 14, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose ASB17061 Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.	Drug: 5 mg ASB17061; Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.
Experimental: Middle dose ASB17061 Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.	Drug: 10 mg ASB17061; Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.
Experimental: High dose ASB17061 Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.	Drug: 20 mg ASB17061; Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Placebo Comparator: Placebo Oral administration of placebo taken once daily for 28 consecutive days.	Drug: Placebo; Oral administration of placebo taken once daily for 28 consecutive days.

Outcome Measures

Primary Outcome Measures

1. Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis [Baseline up to 29 days after initial dose.]

   Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

2. Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis [Baseline up to 29 days after initial dose.]

   Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.

Secondary Outcome Measures

1. Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 [Baseline up to 29 days after initial dose.]

   The investigator provided an overall assessment of the disease severity of the entire body using the EASI. A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); with a negative value indicating decreasing severity of eczema compared to baseline and a decreasing change in the EASI score. A negative value is an indication of a decrease in individual scores.

2. Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 [Baseline up to 29 days after initial dose.]

   Participants' body surface area affected by atopic dermatitis was assessed for the change in percentage after treatment. A negative value indicates a decrease in the percent of body surface area (BSA) involved. A negative value is an indication of a decrease in individual scores.

3. Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 [Baseline up to 29 days after initial dose.]

   Participants assessed the overall intensity of pruritus using a 4-point scale with 0 as the minimum and 3 as the maximum. (0 = absent; 1 = mild; 2 = moderate; and 3 = severe) A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.

4. Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29 [Baseline up to 29 days after initial dose.]

   Participants assessed the extent of their insomnia using an 11-point scale ranging from the minimum, 0 (no insomnia) to the maximum, 10 (severe insomnia). A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.

5. Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis [Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.]

6. Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis [Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.]

   The minimum observed plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.

7. Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis [Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.]

   Pharmacokinetic (PK) metrics of ASB17061 and ASB17584 maximum observed plasma drug concentration (Cmax) in the 4-week Treatment Period were estimated from the individual PK parameters and the actual dosing records.

8. Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis [Baseline up to Predose, up to 0 to 2.5 hours, up to 2.5 to 5 hours, up to 5 to 10 hours, up to Day 29 (24-32 hours).]

   The average plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.

9. Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis [Baseline up to Day 57 follow-up visit post dose.]

   A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Adult subjects ages 18 to 65 years

• A diagnosis of atopic dermatitis (AD)

• An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)

• Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results

• Subjects must be practicing acceptable birth control methods

Exclusion Criteria:

• Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening

• Use of phototherapy or tanning beds within 6 weeks of screening

• Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results

• Female subjects who are pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35233
2		Phoenix	Arizona	United States	85018
3		Rogers	Arkansas	United States	72758
4		Encino	California	United States	91436
5		Fremont	California	United States	94538
6		San Diego	California	United States	92122
7		Temecula	California	United States	92592
8		Denver	Colorado	United States	80220
9		Miami	Florida	United States	33144
10		Miami	Florida	United States	33175
11		Miramar	Florida	United States	33027
12		Saint Augustine	Florida	United States	32086
13		South Tampa	Florida	United States	33609
14		Tampa	Florida	United States	33609
15		Tampa	Florida	United States	33613
16		Savannah	Georgia	United States	31405
17		Boise	Idaho	United States	83704
18		Overland Park	Kansas	United States	66215
19		Crowley	Louisiana	United States	70526
20		Bay City	Michigan	United States	48706
21		Clinton Township	Michigan	United States	48038
22		Fort Gratiot	Michigan	United States	48059
23		Berlin	New Jersey	United States	08009
24		Verona	New Jersey	United States	07044
25		Stony Brook	New York	United States	11790
26		Raleigh	North Carolina	United States	27612
27		Sylvania	Ohio	United States	43560
28		Lake Oswego	Oregon	United States	97035
29		Portland	Oregon	United States	97239
30		Johnston	Rhode Island	United States	02919
31		Arlington	Texas	United States	76011
32		College Station	Texas	United States	77845
33		Pflugerville	Texas	United States	78660
34		San Antonio	Texas	United States	78229
35		Webster	Texas	United States	77598
36		Draper	Utah	United States	84020
37		West Jordan	Utah	United States	84088
38		Henrico	Virginia	United States	23233
39		Norfolk	Virginia	United States	23507
40		Spokane	Washington	United States	99204-4880

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

• Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT01756898
• Other Study ID Numbers: ASBI 704
• First Posted: Dec 28, 2012
• Last Update Posted: Feb 16, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Daiichi Sankyo, Inc.: Atopic Dermatitis; eczema
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

Participant Flow

Recruitment Details	A total of 370 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 42 clinic sites in the United States of America.
Pre-assignment Detail	Adult male and female subjects with active atopic dermatitis (AD) were enrolled in this study.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Period Title: Overall Study
STARTED	92	92	93	93
COMPLETED	73	73	76	77
NOT COMPLETED	19	19	17	16

Baseline Characteristics

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose	Total
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).	Total of all reporting groups
Overall Participants	91	90	92	93	366
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.0 (13.34)	36.9 (14.34)	37.1 (14.82)	39 (13.71)	37.7 (14.27)
Sex: Female, Male (Count of Participants)
Female	60 65.9%	68 75.6%	60 65.2%	72 77.4%	260 71%
Male	31 34.1%	22 24.4%	32 34.8%	21 22.6%	106 29%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	22 24.2%	19 21.1%	21 22.8%	22 23.7%	84 23%
Not Hispanic or Latino	69 75.8%	71 78.9%	71 77.2%	71 76.3%	282 77%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	6 6.6%	2 2.2%	6 6.5%	6 6.5%	20 5.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	26 28.6%	25 27.8%	21 22.8%	23 24.7%	95 26%
White	55 60.4%	58 64.4%	62 67.4%	60 64.5%	235 64.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	4 4.4%	5 5.6%	3 3.3%	4 4.3%	16 4.4%
Region of Enrollment (participants) [Number]
United States	91 100%	90 100%	92 100%	93 100%	366 100%

Outcome Measures

1. Primary Outcome

Title	Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Description	Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Time Frame	Baseline up to 29 days after initial dose.

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess IGA.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	91	90	92	93
Count of Participants [Participants]	20 22%	21 23.3%	19 20.7%	18 19.4%

2. Primary Outcome

Title	Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Description	Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.
Time Frame	Baseline up to 29 days after initial dose.

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess IGA by subgroup.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	91	90	92	93
Male	1 1.1%	3 3.3%	7 7.6%	7 7.5%
Female	19 20.9%	18 20%	12 13%	11 11.8%
White	13 14.3%	12 13.3%	14 15.2%	13 14%
Black or African American	6 6.6%	6 6.7%	4 4.3%	4 4.3%
Other	1 1.1%	3 3.3%	1 1.1%	1 1.1%
Baseline EASI score <15	18 19.8%	20 22.2%	18 19.6%	17 18.3%
Baseline EASI score ≥15	2 2.2%	1 1.1%	1 1.1%	1 1.1%
Baseline Lichenification severity 0-3	15 16.5%	9 10%	10 10.9%	8 8.6%
Baseline Lichenification severity 4-12	5 5.5%	12 13.3%	9 9.8%	10 10.8%
Baseline % BSA involved <15%	16 17.6%	19 21.1%	16 17.4%	15 16.1%
Baseline % BSA involved ≥15%	4 4.4%	2 2.2%	3 3.3%	3 3.2%
Baseline IGA score = 2	9 9.9%	9 10%	10 10.9%	8 8.6%
Baseline IGA score = 3	11 12.1%	12 13.3%	8 8.7%	9 9.7%
Baseline IGA score = 4 or 5	0 0%	0 0%	1 1.1%	1 1.1%
Baseline IGA score = 3, 4, or 5	11 12.1%	12 13.3%	9 9.8%	10 10.8%
Allergic rhinitis/Asthma absent	10 11%	10 11.1%	8 8.7%	13 14%
Allergic rhinitis/Asthma present	10 11%	11 12.2%	11 12%	5 5.4%
Baseline Immunoglobulin (IgE) <100 IU/mL	14 15.4%	10 11.1%	13 14.1%	11 11.8%
Baseline Immunoglobulin (IgE) ≥100 IU/mL	6 6.6%	10 11.1%	6 6.5%	7 7.5%

3. Secondary Outcome

Title	Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description	The investigator provided an overall assessment of the disease severity of the entire body using the EASI. A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); with a negative value indicating decreasing severity of eczema compared to baseline and a decreasing change in the EASI score. A negative value is an indication of a decrease in individual scores.
Time Frame	Baseline up to 29 days after initial dose.

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess EASI.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	91	90	92	93
Baseline	12.6 (11.2)	12.2 (9.67)	11.2 (9.12)	11.7 (9.96)
Day 29	-3.43 (7.96)	-3.24 (7.45)	-3.51 (6.75)	-2.75 (4.77)

4. Secondary Outcome

Title	Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description	Participants' body surface area affected by atopic dermatitis was assessed for the change in percentage after treatment. A negative value indicates a decrease in the percent of body surface area (BSA) involved. A negative value is an indication of a decrease in individual scores.
Time Frame	Baseline up to 29 days after initial dose.

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess the percent Body Surface Area.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	91	90	92	93
Baseline	21.0 (20.87)	19.6 (21.96)	18.5 (19.00)	18.1 (17.29)
Day 29	-3.59 (7.69)	-2.99 (9.44)	-2.95 (6.23)	-3.27 (6.50)

5. Secondary Outcome

Title	Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description	Participants assessed the overall intensity of pruritus using a 4-point scale with 0 as the minimum and 3 as the maximum. (0 = absent; 1 = mild; 2 = moderate; and 3 = severe) A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Time Frame	Baseline up to 29 days after initial dose.

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess pruritus score.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	91	90	92	93
Baseline	2.3 (0.74)	2.4 (0.68)	2.2 (0.72)	2.5 (0.64)
Day 29	-0.75 (1.00)	-0.80 (0.97)	-0.72 (1.03)	-0.76 (0.90)

6. Secondary Outcome

Title	Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description	Participants assessed the extent of their insomnia using an 11-point scale ranging from the minimum, 0 (no insomnia) to the maximum, 10 (severe insomnia). A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Time Frame	Baseline up to 29 days after initial dose.

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess the insomnia score.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	91	90	92	93
Baseline	4.0 (3.13)	3.9 (3.09)	3.7 (3.30)	3.6 (2.76)
Day 29	-1.10 (2.69)	-1.06 (2.76)	-1.20 (3.02)	-0.97 (2.20)

7. Secondary Outcome

Title	Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Time Frame	Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.

Outcome Measure Data

Analysis Population Description

The Pharmacokinetic (PK) sample analyses were performed on the PK Population. Only plasma samples from active participants were analyzed for ASB17061 and ASB17584 concentrations.

Arm/Group Title	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	92	93	93
Predose ASB17061	NA (NA)	NA (NA)	NA (NA)
0 to 2.5 hours ASB17061	24.4 (18.7)	48.3 (51.4)	89.6 (78.6)
2.5 to 5 hours ASB17061	18.3 (13.7)	33.3 (24.9)	72.7 (48.2)
5 to 10 hours ASB17061	8.03 (9.15)	18.0 (20.6)	38.8 (55.2)
Day 29 (24-32 hours) ASB17061	3.07 (6.30)	5.32 (15.2)	3.35 (8.27)
Predose ASB17584	NA (NA)	NA (NA)	NA (NA)
0 to 2.5 hours ASB17584	9.21 (7.63)	18.1 (17.1)	27.3 (25.2)
2.5 to 5 hours ASB17584	7.50 (5.60)	14.4 (13.0)	30.7 (21.3)
5 to 10 hours ASB17584	2.98 (3.67)	6.29 (6.16)	15.1 (20.5)
Day 29 (24-32 hours) ASB17584	2.40 (4.21)	2.31 (3.11)	2.11 (4.24)

8. Secondary Outcome

Title	Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Description	The minimum observed plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Time Frame	Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.

Outcome Measure Data

Analysis Population Description

The Cmin was assessed in the Efficacy Evaluable (EE) Population.

Arm/Group Title	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	71	72	82
Cmin ASB17061	0.88 (2.09)	1.34 (0.94)	2.43 (2.44)
Cmin ASB17584	0.58 (0.76)	0.97 (0.69)	1.82 (1.58)

9. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Description	Pharmacokinetic (PK) metrics of ASB17061 and ASB17584 maximum observed plasma drug concentration (Cmax) in the 4-week Treatment Period were estimated from the individual PK parameters and the actual dosing records.
Time Frame	Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.

Outcome Measure Data

Analysis Population Description

The Cmax was assessed in the Efficacy Evaluable (EE)Population.

Arm/Group Title	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	71	72	82
Cmax ASB17061	33.82 (13.67)	67.60 (19.39)	134.90 (53.94)
Cmax ASB17584	11.27 (4.24)	22.25 (8.79)	42.73 (15.36)

10. Secondary Outcome

Title	Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Description	The average plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Time Frame	Baseline up to Predose, up to 0 to 2.5 hours, up to 2.5 to 5 hours, up to 5 to 10 hours, up to Day 29 (24-32 hours).

Outcome Measure Data

Analysis Population Description

The Cavg was analyzed in the Efficacy Evaluable Population.

Arm/Group Title	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	71	72	82
Cavg ASB17061	5.59 (3.57)	11.04 (4.21)	21.88 (10.30)
Cavg ASB17584	2.16 (1.21)	4.18 (2.04)	8.30 (3.84)

11. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Description	A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
Time Frame	Baseline up to Day 57 follow-up visit post dose.

Outcome Measure Data

Analysis Population Description

Treatment-emergent adverse events (TEAEs) were assessed in the Safety Population.

Arm/Group Title	Placebo	ASB17061 5 mg Low Dose	ASB17061 10 mg Middle Dose	ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.	Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).	Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
Measure Participants	92	92	93	93
Bronchitis	0 0%	2 2.2%	3 3.3%	1 1.1%
Influenza	1 1.1%	0 0%	4 4.3%	0 0%
Nasopharyngitis	4 4.4%	7 7.8%	7 7.6%	6 6.5%
Sinusitis	1 1.1%	2 2.2%	0 0%	1 1.1%
Upper respiratory tract infection	4 4.4%	3 3.3%	4 4.3%	2 2.2%
Urinary tract infection	0 0%	3 3.3%	2 2.2%	2 2.2%
Abdominal pain	2 2.2%	0 0%	1 1.1%	2 2.2%
Abdominal pain upper	1 1.1%	1 1.1%	2 2.2%	2 2.2%
Constipation	0 0%	2 2.2%	0 0%	1 1.1%
Diarrhea	4 4.4%	2 2.2%	4 4.3%	5 5.4%
Dyspepsia	0 0%	2 2.2%	0 0%	0 0%
Flatulence	2 2.2%	3 3.3%	2 2.2%	0 0%
Nausea	2 2.2%	1 1.1%	2 2.2%	4 4.3%
Vomiting	2 2.2%	2 2.2%	5 5.4%	2 2.2%
Dermatitis atopic	3 3.3%	8 8.9%	5 5.4%	3 3.2%
Dermatitis contact	2 2.2%	0 0%	0 0%	0 0%
Eczema	0 0%	1 1.1%	2 2.2%	1 1.1%
Pruritis	1 1.1%	0 0%	2 2.2%	2 2.2%
Urticaria	0 0%	0 0%	3 3.3%	0 0%
Headache	4 4.4%	9 10%	6 6.5%	9 9.7%
Somnolence	1 1.1%	0 0%	3 3.3%	0 0%
Aspartate aminotransferase increased	2 2.2%	0 0%	1 1.1%	0 0%
Blood creatine phosphokinase increased	6 6.6%	0 0%	4 4.3%	2 2.2%
Blood testosterone decreased	3 3.3%	0 0%	0 0%	1 1.1%
Hepatic enzyme increased	2 2.2%	0 0%	0 0%	0 0%
White blood cell count increased	0 0%	0 0%	0 0%	2 2.2%
Cough	1 1.1%	2 2.2%	1 1.1%	2 2.2%
Oropharyngeal pain	1 1.1%	2 2.2%	3 3.3%	0 0%
Rhinorrhea	2 2.2%	1 1.1%	0 0%	0 0%
Myalgia	1 1.1%	3 3.3%	1 1.1%	2 2.2%
Fatigue	2 2.2%	2 2.2%	1 1.1%	0 0%
Arthropod bite	0 0%	0 0%	2 2.2%	0 0%
Ligament sprain	0 0%	0 0%	2 2.2%	0 0%
Insomnia	0 0%	2 2.2%	2 2.2%	0 0%
Polyuria	0 0%	2 2.2%	0 0%	0 0%
Ovarian cyst	0 0%	2 2.2%	0 0%	0 0%
Hypertension	0 0%	0 0%	2 2.2%	0 0%

Adverse Events

Time Frame	Baseline up to 12 weeks after the initial dose.
Adverse Event Reporting Description	A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
Arm/Group Title	Placebo		ASB17061 5 mg Low Dose		ASB17061 10 mg Middle Dose		ASB17061 20 mg High Dose
Arm/Group Description	Participants with atopic dermatitis were randomized to receive a placebo.		Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).		Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).		Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
All Cause Mortality
	Placebo		ASB17061 5 mg Low Dose		ASB17061 10 mg Middle Dose		ASB17061 20 mg High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		0/92 (0%)		0/93 (0%)		0/93 (0%)
Serious Adverse Events
	Placebo		ASB17061 5 mg Low Dose		ASB17061 10 mg Middle Dose		ASB17061 20 mg High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		1/92 (1.1%)		0/93 (0%)		0/93 (0%)
Congenital, familial and genetic disorders
Bilateral Clubfoot	0/92 (0%)		1/92 (1.1%)		0/93 (0%)		0/93 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		ASB17061 5 mg Low Dose		ASB17061 10 mg Middle Dose		ASB17061 20 mg High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/92 (47.8%)		51/92 (55.4%)		54/93 (58.1%)		45/93 (48.4%)
Gastrointestinal disorders
Diarrhea	10/92 (10.9%)		15/92 (16.3%)		16/93 (17.2%)		10/93 (10.8%)
General disorders
General disorders and administration site conditions	5/92 (5.4%)		3/92 (3.3%)		3/93 (3.2%)		2/93 (2.2%)
Infections and infestations
Nasopharyngitis	13/92 (14.1%)		25/92 (27.2%)		24/93 (25.8%)		17/93 (18.3%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	1/92 (1.1%)		1/92 (1.1%)		5/93 (5.4%)		2/93 (2.2%)
Investigations
Blood creatine phosphokinase increased	13/92 (14.1%)		1/92 (1.1%)		7/93 (7.5%)		8/93 (8.6%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	5/92 (5.4%)		4/92 (4.3%)		2/93 (2.2%)		7/93 (7.5%)
Nervous system disorders
Headache	6/92 (6.5%)		9/92 (9.8%)		10/93 (10.8%)		9/93 (9.7%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	4/92 (4.3%)		8/92 (8.7%)		5/93 (5.4%)		5/93 (5.4%)
Skin and subcutaneous tissue disorders
Dermatitis atopic	8/92 (8.7%)		11/92 (12%)		10/93 (10.8%)		7/93 (7.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.