Clinical trial NCT03619902: A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
Official title: A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Pustular Psoriasis
Keywords: GPP
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale
timeFrame: Week 4 and Week 16
measure: Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16
timeFrame: Baseline, Week 1, Week 4, and Week 16
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 1, Week 4, and Week 16
measure: 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
timeFrame: Week 1, Week 4, and Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16
timeFrame: Baseline and Week 1, Week 4, and Week 16
Other outcomes:
Locations:
city: Encino
country: United States
facility: Site 102
state: California
city: Largo
country: United States
facility: Site 105
state: Florida
city: Miami
country: United States
facility: Site 104
state: Florida
city: Indianapolis
country: United States
facility: Site 101
state: Indiana
city: Ann Arbor
country: United States
facility: Site 100
state: Michigan
city: Seoul
country: Korea, Republic of
facility: Site 501
city: Olsztyn
country: Poland
facility: Site 304
city: Rzeszów
country: Poland
facility: Site 301
city: Łódź
country: Poland
facility: Site 303
city: Łódź
country: Poland
facility: Site 302
city: London
country: United Kingdom
facility: Site 201
city: Newcastle Upon Tyne
country: United Kingdom
facility: Site 203
city: Salford
country: United Kingdom
facility: Site 202
Study officials:
affiliation: AnaptysBio, Inc.
name: Irina Khanskaya, MD
role: STUDY_DIRECTOR
References: