Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation

Psoriasis Clinical Trial

— IMMPRESS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518047
• Other study ID #: M16-176
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2018
• Est. completion date: February 11, 2020

Study information

• Verified date: January 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• risankizumab
rizankizumab subcutaneous (SC) infusion
• placebo for rizankizumab
placebo for rizankizumab subcutaneous (SC) infusion

Locations

Country	Name	City	State
Russian Federation	Alliance Biomedical Ural Group /ID# 201681	Izhevsk	Udmurtskaya Respublika
Russian Federation	Family Outpatient clinic#4 LLC /ID# 207441	Korolev	Moskva
Russian Federation	GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713	Krasnodar	Krasnodarskiy Kray
Russian Federation	LLC ArsVitae Severo-Zapad /ID# 200658	Saint-Petersburg	Sankt-Peterburg
Russian Federation	LLC Kurator /ID# 200616	Saint-Petersburg	Sankt-Peterburg
Russian Federation	SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615	Saint-Petersburg	Sankt-Peterburg

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16	The PASI score is an established measure of clinical efficacy for psoriasis medications.	Week 16
Secondary	Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16	The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.	Week 16
Secondary	Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16	The PASI score is an established measure of clinical efficacy for psoriasis medications.	Week 16
Secondary	Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16	The PASI score is an established measure of clinical efficacy for psoriasis medications.	Week 16
Secondary	Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16	The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).	Week 16

External Links

•   clinical study report synopsis