NCT03518047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 19, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

May 4, 2018

Last Update Submit

January 22, 2021

Conditions

Psoriasis

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16

    Week 16

  • Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16

    Week 16

  • Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16

    Week 16

  • Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

    Week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for risankizumab by subcutaneous (SC) injection.

Drug: placebo for rizankizumab

Risankizumab

EXPERIMENTAL

Risankizumab by subcutaneous (SC) injection.

Drug: risankizumab

Interventions

risankizumabDRUG

rizankizumab subcutaneous (SC) infusion

Also known as: ABBV-066, BI 655066
Risankizumab
placebo for rizankizumabDRUG

placebo for rizankizumab subcutaneous (SC) infusion

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713

Krasnodar, Krasnodarskiy Kray, 350020, Russia

Location

Family Outpatient clinic#4 LLC /ID# 207441

Korolev, Moscow, 141060, Russia

Location

SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615

Saint Petersburg, Sankt-Peterburg, 194021, Russia

Location

LLC ArsVitae Severo-Zapad /ID# 200658

Saint Petersburg, Sankt-Peterburg, 194223, Russia

Location

LLC Kurator /ID# 200616

Saint Petersburg, Sankt-Peterburg, 196240, Russia

Location

Alliance Biomedical Ural Group /ID# 201681

Izhevsk, Udmurtiya Republic, 426061, Russia

Location

Related Publications (1)

  • 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.

    PMID: 35917057DERIVED

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 8, 2018

Study Start

July 19, 2018

Primary Completion

February 11, 2020

Study Completion

February 11, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information

Locations

RU(6)