Clinical trial NCT03518047: Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation
Official title: Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
* Moderate to severe chronic plaque psoriasis at both Screening and Baseline (Randomization) Visits
* Candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator

Exclusion Criteria:

* Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19 inhibitor
* Concurrent therapy with a biologic and/or other systemic therapy

Primary outcomes:
measure: Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16
timeFrame: Week 16
measure: Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16
timeFrame: Week 16
measure: Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16
timeFrame: Week 16
measure: Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713
state: Krasnodarskiy Kray
city: Korolev
country: Russian Federation
facility: Family Outpatient clinic#4 LLC /ID# 207441
state: Moskva
city: Saint-Petersburg
country: Russian Federation
facility: SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: LLC ArsVitae Severo-Zapad /ID# 200658
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: LLC Kurator /ID# 200616
state: Sankt-Peterburg
city: Izhevsk
country: Russian Federation
facility: Alliance Biomedical Ural Group /ID# 201681
state: Udmurtskaya Respublika
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Odnopozova L, Edin A, Sukharev A, Wu T, Aydin K, Kelly M, Khotko A. Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. Dermatol Ther (Heidelb). 2022 Sep;12(9):2063-2075. doi: 10.1007/s13555-022-00776-0. Epub 2022 Aug 2.