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Monoclonal Antibodies

Risankizumab for Ulcerative Colitis

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 300

Awards & highlights

Study Summary

This trial will assess the safety and efficacy of risankizumab as a treatment for ulcerative colitis. The study will last for 52 weeks and will compare the results of those taking risankizumab to those taking a placebo.

Who is the study for?

This trial is for people with ulcerative colitis who responded to risankizumab in a previous study. They must not have allergies to risankizumab, its ingredients, or substances from Chinese hamster ovary cells. Participants should be compliant with medication requirements from the prior study.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of risankizumab over 52 weeks compared to a placebo. It includes three sub-studies: one double-blind controlled study, one exploratory study, and an open-label extension for certain participants affected by COVID-19 or geopolitical issues.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions to risankizumab or its components. Side effects experienced in the earlier phase of the trial could also be relevant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 300

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 300

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 300 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AE)

Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score

Secondary outcome measures

Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms

+14 more

Side effects data

From 2020 Phase 3 trial • 18 Patients • NCT03022045

25%

Urticaria

25%

Osteoarthritis

25%

Rash

25%

Intervertebral disc protrusion

25%

Hepatic function abnormal

25%

Alanine aminotransferase increased

25%

Aspartate aminotransferase increased

25%

Erythema

25%

Viral upper respiratory tract infection

25%

Gamma-glutamyltransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

GPP Risankizumab 75 mg

GPP Risankizumab 150 mg

EP Risankizumab 75 mg

EP Risankizumab 150 mg

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Substudy 3: OL Extension RisankizumabExperimental Treatment1 Intervention

Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.

Group II: Substudy 2: Open-label (OL) Clinical Assessment RisankizumabExperimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Group III: Substudy 2: OL Therapeutic Drug Monitoring RisankizumabExperimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Group IV: Substudy 1: Double-blind Risankizumab Dose 2Experimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.

Group V: Substudy 1: Double-blind Risankizumab Dose 1Experimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Group VI: OL Continuous Treatment Extension - Dose 2Experimental Treatment1 Intervention

Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.

Group VII: OL Continuous Treatment Extension - Dose 1Experimental Treatment1 Intervention

Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.

Group VIII: Substudy 1: Double-blind PlaceboPlacebo Group1 Intervention

Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

risankizumab

2016

Completed Phase 3

~5550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

499,863 Total Patients Enrolled

30 Trials studying Ulcerative Colitis

20,212 Patients Enrolled for Ulcerative Colitis

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

144,697 Total Patients Enrolled

16 Trials studying Ulcerative Colitis

15,098 Patients Enrolled for Ulcerative Colitis

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03398135 — Phase 3

Ulcerative Colitis Research Study Groups: OL Continuous Treatment Extension - Dose 1, OL Continuous Treatment Extension - Dose 2, Substudy 1: Double-blind Risankizumab Dose 2, Substudy 2: OL Therapeutic Drug Monitoring Risankizumab, Substudy 3: OL Extension Risankizumab, Substudy 2: Open-label (OL) Clinical Assessment Risankizumab, Substudy 1: Double-blind Placebo, Substudy 1: Double-blind Risankizumab Dose 1

Ulcerative Colitis Clinical Trial 2023: Risankizumab Highlights & Side Effects. Trial Name: NCT03398135 — Phase 3

Risankizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03398135 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hypotheses does this research aim to confirm or refute?

"The primary outcome that will be measured over a 300-week period is the percentage of participants with clinical remission per adapted Mayo score, according to the trial sponsor, AbbVie. Additionally, this study will assess secondary outcomes including the percentage of participants with mucosal healing, defined as mucosal healing defined as endoscopic and histologic remission; the percentage of participants with clinical remission per full Mayo score in participants with a full Mayo score of 6 to 12 at baseline (of induction), defined as clinical remission per full Mayo score; and the percentage of participants with histologic remission, defined as histologic remission per Geboes score"

Answered by AI

What are the main conditions that risankizumab has been designed to help?

"Risankizumab is an effective medical intervention for three distinct conditions:Dental plaque, psoriasis, and skin disinfection therapy."

Answered by AI

Has the FDA cleared risankizumab for use?

"Since this is a Phase 3 trial, there is more data supporting the safety of risankizumab than other medications."

Answered by AI

Are there other instances of risankizumab being used in research?

"Risankizumab was first researched in 2011 at the renowned Memorial Sloan Kettering Cancer Center. So far, there have been a total of 99 completed trials. Right now, there are 31 risankizumab studies actively recruiting patients; many of these are based in Houston, Connecticut."

Answered by AI