GPP: A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis

• Sponsor: AnaptysBio, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03619902
• Collaborator: (none)
• Enrollment: 8
• Locations: 13
• Arm: 1
• Actual Duration (Months): 23.7
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.

Condition or Disease	Intervention/Treatment	Phase
Generalized Pustular Psoriasis	Biological: Imsidolimab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis
• Actual Study Start Date: Jan 30, 2019
• Actual Primary Completion Date: Jan 20, 2021
• Actual Study Completion Date: Jan 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Imsidolimab Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.	Biological: Imsidolimab; Humanized monoclonal antibody; Other Names: ANB019

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale [Week 4 and Week 16]

   Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: Very Much Improved: Reduction in JDA-SI total score by 3 or > points; Much improved: Reduction in JDA-SI total score by 1 or 2 points; Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by <20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.

2. Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 [Baseline, Week 1, Week 4, and Week 16]

Secondary Outcome Measures

1. Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 [Baseline, Week 1, Week 4, and Week 16]

   The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale: 0: 0% body surface area (BSA) affected; 1: > 0%, < 10% BSA affected; 2: ≥ 10%, < 50% BSA affected; 3: ≥ 50% BSA affected. The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement.

2. Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 [Week 1, Week 4, and Week 16]

   The GPPPGA scale was used to assess the impact and severity of GPP on the following scale: 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting). 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions). 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting). 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions). 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions).

3. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 [Baseline and Week 1, Week 4, and Week 16]

   The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of active GPP

• Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)

• Must be candidates for systemic therapy or phototherapy

Exclusion Criteria:

• Erythrodermic, guttate psoriasis, drug induced GPP

• Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy

• History of recurrent or chronic infection

• ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 102	Encino	California	United States	91436
2	Site 105	Largo	Florida	United States	33771
3	Site 104	Miami	Florida	United States	33316
4	Site 101	Indianapolis	Indiana	United States	46250
5	Site 100	Ann Arbor	Michigan	United States	48109
6	Site 501	Seoul		Korea, Republic of	03722
7	Site 304	Olsztyn		Poland	10-229
8	Site 301	Rzeszów		Poland	35-055
9	Site 303	Łódź		Poland	90-436
10	Site 302	Łódź		Poland
11	Site 201	London		United Kingdom
12	Site 203	Newcastle Upon Tyne		United Kingdom
13	Site 202	Salford		United Kingdom

Sponsors and Collaborators

• AnaptysBio, Inc.

Investigators

• Study Director: Irina Khanskaya, MD, AnaptysBio, Inc.

Study Documents (Full-Text)

• Study Protocol - Oct 29, 2019
• Statistical Analysis Plan - Sep 9, 2019

More Information

Additional Information:

• Related Information

Publications

None provided.

• Responsible Party: AnaptysBio, Inc.
• ClinicalTrials.gov Identifier: NCT03619902
• Other Study ID Numbers: ANB019-002; 2017-004021-33
• First Posted: Aug 8, 2018
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• 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
• Keywords provided by AnaptysBio, Inc.: GPP
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	This study was conducted at 5 centers that enrolled subjects in the United Kingdom and Poland.
Pre-assignment Detail	The study included a screening period of up to 42 days, a 12-week treatment period, and a 12-week safety follow-up period. A total of 12 subjects were screened, with 8 subjects being enrolled in the study.

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.
Period Title: Overall Study
STARTED	8
COMPLETED	6
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
Overall Participants	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.3 (14.91)
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	8 100%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 12.5%
Black or African American	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
White	7 87.5%
Region of Enrollment (participants) [Number]
Poland	5 62.5%
United Kingdom	3 37.5%
Modified Japanese Dermatological Association Severity Index (JDA-SI) Total Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	9.1 (2.75)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale
Description	Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: Very Much Improved: Reduction in JDA-SI total score by 3 or > points; Much improved: Reduction in JDA-SI total score by 1 or 2 points; Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by <20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.
Time Frame	Week 4 and Week 16

Outcome Measure Data

Analysis Population Description

The full analysis set (FAS) included all enrolled participants. Participants with missing data were categorized as non-responders.

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
Measure Participants	8
Week 4	75.0 937.5%
Week 16	75.0 937.5%

2. Primary Outcome

Title	Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16
Time Frame	Baseline, Week 1, Week 4, and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set participants with available data at each time point

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
Measure Participants	8
Week 1	-59.63 (39.895)
Week 4	-94.17 (10.737)
Week 16	-97.78 (5.443)

3. Secondary Outcome

Title	Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16
Description	The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale: 0: 0% body surface area (BSA) affected; 1: > 0%, < 10% BSA affected; 2: ≥ 10%, < 50% BSA affected; 3: ≥ 50% BSA affected. The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement.
Time Frame	Baseline, Week 1, Week 4, and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set participants with available data at each time point

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
Measure Participants	8
Week 1	-25.74 (26.369)
Week 4	-55.65 (27.157)
Week 16	-62.20 (29.757)

4. Secondary Outcome

Title	Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16
Description	The GPPPGA scale was used to assess the impact and severity of GPP on the following scale: 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting). 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions). 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting). 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions). 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions).
Time Frame	Week 1, Week 4, and Week 16

Outcome Measure Data

Analysis Population Description

Full Analysis Set participants with GPPPGA at Baseline and at each time point

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
Measure Participants	5
Week 1	0.0 0%
Week 4	50.0 625%
Week 16	75.0 937.5%

5. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16
Description	The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.
Time Frame	Baseline and Week 1, Week 4, and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set participants with available data at each time point

Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
Measure Participants	8
Week 1	-0.9 (0.356)
Week 4	-6.0 (9.08)
Week 16	-10.7 (9.16)

Adverse Events

Time Frame	From first dose of study treatment up to end of follow-up period; 24 weeks.
Arm/Group Title	Imsidolimab
Arm/Group Description	Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
All Cause Mortality
	Imsidolimab
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Imsidolimab
	Affected / at Risk (%)	# Events
Total	2/8 (25%)
Infections and infestations
COVID-19	1/8 (12.5%)	1
Nosocomial infection	1/8 (12.5%)	1
Other (Not Including Serious) Adverse Events
	Imsidolimab
	Affected / at Risk (%)	# Events
Total	6/8 (75%)
Blood and lymphatic system disorders
Anaemia	1/8 (12.5%)	1
Lymphadenopathy	1/8 (12.5%)	3
Cardiac disorders
Mitral valve prolapse	1/8 (12.5%)	1
Myxomatous mitral valve degeneration	1/8 (12.5%)	1
General disorders
Peripheral swelling	1/8 (12.5%)	1
Swelling face	1/8 (12.5%)	1
Injury, poisoning and procedural complications
Humerus fracture	1/8 (12.5%)	1
Investigations
Blood folate decreased	1/8 (12.5%)	1
Blood glucose increased	1/8 (12.5%)	1
C-reactive protein increased	1/8 (12.5%)	1
White blood cell count increased	1/8 (12.5%)	1
Metabolism and nutrition disorders
Hypokalemia	1/8 (12.5%)	1
Nervous system disorders
Presyncope	1/8 (12.5%)	1
Renal and urinary disorders
Acute kidney injury	1/8 (12.5%)	1
Reproductive system and breast disorders
Vaginal haemorrhage	1/8 (12.5%)	1
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	2/8 (25%)	2
Skin and subcutaneous tissue disorders
Psoriasis	1/8 (12.5%)	1
Skin haemorrhage	1/8 (12.5%)	1
Vascular disorders
Hypertension	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI may not publish trial results until after the first multi-center publication unless such publication is not published within a period that is at least 18 months but less than or equal to 24 months after trial completion. In addition, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.