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Monoclonal Antibodies

risankizumab SC for Ulcerative Colitis

Phase 2 & 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
Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial is testing a new medication for ulcerative colitis. The first part is to see if it works and what the best dose is. The second part is to see if it works better than a placebo.

Eligible Conditions
  • Ulcerative Colitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have tried traditional medication and tofacitinib, as well as one or more biologic therapies, but they did not work well for you or you had negative side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sub-Study 1 and Sub-Study 2: 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 Short Form-36 (SF-36)
+24 more

Side effects data

From 2021 Phase 3 trial • 618 Patients • NCT03104413
5%
HEADACHE
4%
NASOPHARYNGITIS
4%
ARTHRALGIA
3%
CROHN'S DISEASE
2%
NAUSEA
1%
ANAEMIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Induction Period 1)
Risankizumab 600mg (Induction Period 1)
Risankizumab Dose 180mg (Induction Period 2)
Period 1 Risankizumab Total
Risankizumab 360mg (Induction Period 2)
Placebo/Risankizumab 1200mg (Induction Period 2)
Period 2 Risankizumab Total
Risankizumab 1200mg (Induction Period 1)
Risankizumab 1200mg (Induction Period 2)

Trial Design

15Treatment groups
Experimental Treatment
Placebo Group
Group I: Substudy 2, Induction 2: Double-blind Risankizumab Dose 3Experimental Treatment1 Intervention
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
Group II: Substudy 2, Induction 2: Double-blind Risankizumab Dose 2Experimental Treatment1 Intervention
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
Group III: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)Experimental Treatment1 Intervention
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Group IV: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)Experimental Treatment1 Intervention
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Group V: Substudy 2, Induction 1: Double-blind Risankizumab Dose 1Experimental Treatment1 Intervention
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Group VI: Substudy 1, Induction 2: Double-blind Risankizumab Dose 3Experimental Treatment1 Intervention
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
Group VII: Substudy 1, Induction 2: Double-blind Risankizumab Dose 2Experimental Treatment1 Intervention
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
Group VIII: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)Experimental Treatment1 Intervention
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Group IX: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)Experimental Treatment1 Intervention
Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Group X: Substudy 1, Induction 1: Open-label Risankizumab Dose 1Experimental Treatment1 Intervention
Participants receive risankizumab dose 1 administered by intravenous (IV) infusion.
Group XI: Substudy 1, Induction 1: Double-blind Risankizumab Dose 3Experimental Treatment1 Intervention
Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.
Group XII: Substudy 1, Induction 1: Double-blind Risankizumab Dose 2Experimental Treatment1 Intervention
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Group XIII: Substudy 1, Induction 1: Double-blind Risankizumab Dose 1Experimental Treatment1 Intervention
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Group XIV: Substudy 2, Induction 1: Double-blind PlaceboPlacebo Group2 Interventions
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Group XV: Substudy 1, Induction 1: Double-blind PlaceboPlacebo Group1 Intervention
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
risankizumab IV
2017
Completed Phase 3
~3230
risankizumab SC
2017
Completed Phase 3
~3230

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
494,914 Total Patients Enrolled
30 Trials studying Ulcerative Colitis
19,896 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
139,595 Total Patients Enrolled
16 Trials studying Ulcerative Colitis
14,782 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

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

Does this experimental treatment only cater to young adults?

"The minimum age for this clinical trial is 16 and the maximum age is 80, as specified in the eligibility requirements."

Answered by AI

How can I qualify to take part in this clinical research project?

"This trial is looking for 1554 participants with ulcerative colitis between the ages of 16 and 80. Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control, and males or females must be aged 18 to 80 years at the Baseline Visit. Subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit may also be eligible. Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline, active UC as assessed by Adapted Mayo Score and Endoscopic Subscore"

Answered by AI

How is risankizumab SC most often employed?

"risankizumab SC is indicated for use in patients that might respond to phototherapy, as well as those suffering from moderate to severe plaque psoriasis, who have an inadequate response or intolerance to disease-modifying antirheumatic drugs, and dental plaque."

Answered by AI

How many people can join this test group and still have it be considered reliable?

"This trial is no longer recruiting patients. The study was posted on 3/7/2018 and was last edited on 8/29/2022. For those still exploring their options, there are 425 other studies for colitis, ulcerative and 16 for risankizumab SC that are actively recruiting patients."

Answered by AI

Are there other instances where risankizumab SC has been used in a medical study?

"Risankizumab SC is being studied in 16 different ongoing clinical trials, 13 of which are in Phase 3. Many of the research sites for risankizumab SC are located in Gdansk, Pomorskie, but there are 3193 total locations for these trials."

Answered by AI

Are patients still being accepted for participation in this research project?

"This particular trial, which was last updated on 8/29/2022, is not actively recruiting patients according to the latest information from clinicaltrials.gov. However, there are 441 other medical studies that are actively looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Digestive Disease Consultants /ID# 209798
What portion of applicants met pre-screening criteria?
Met criteria
~223 spots leftby Mar 2025