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Monoclonal Antibodies

Risankizumab for Crohn's Disease

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

Participants have completed the study M16-006 or M15-991 and have achieved clinical response

Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 220

Awards & highlights

Study Summary

This trial is testing a new medication, risankizumab, as a possible treatment for Crohn's disease. The study will compare the efficacy and safety of risankizumab to a placebo, as well as to different dosing regimens of risankizumab. The study will also look at the long-term safety of risankizumab.

Who is the study for?

This trial is for people with moderately to severely active Crohn's Disease who've had a positive response to risankizumab in previous studies. They should be willing and able to self-inject the medication using an on-body injector, have been stable on their current dose for at least 16 weeks, and not require rescue treatment.Check my eligibility

What is being tested?

The study tests the effectiveness of risankizumab as a maintenance therapy through four sub-studies: comparing it against placebo, exploring dosing regimens, assessing long-term safety and efficacy, and evaluating patient outcomes when administered via an On-Body Injector.See study design

What are the potential side effects?

Risankizumab may cause side effects such as infections due to immune system suppression, allergic reactions if sensitive to its components or Chinese hamster ovary ingredients. Long-term risks include potential lymphoproliferative disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed study M16-006 or M15-991 and my condition improved.

Select...

I've been on a stable dose of risankizumab for over 16 weeks and passed 72 weeks in Sub-study 3 without needing rescue medication.

Select...

I completed study M16-006 or M15-991 and my condition improved.

Select...

I have been on a stable dose of risankizumab for over 16 weeks and passed 72 weeks in Sub-study 3 without needing rescue medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 220

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 220

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 220 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: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Sub-Study 1: Percentage of Participants With Endoscopic Response

Sub-Study 3: Number of Participants With Adverse Events

+4 more

Secondary outcome measures

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

Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline

Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission

+9 more

Other outcome measures

Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

Sub-Study 2: Percentage of Participants With Endoscopic Response

Sub-Study 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Risankizumab On-Body Injector and Open Label (Sub-Study 4)Experimental Treatment2 Interventions

Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.

Group II: Open-label Risankizumab (Sub-Study 3)Experimental Treatment1 Intervention

Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.

Group III: Maintenance Risankizumab Dose 2 (Sub-Study 2)Experimental Treatment3 Interventions

Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Group IV: Maintenance Risankizumab Dose 1 (Sub-Study 2)Experimental Treatment2 Interventions

Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.

Group V: Double-blind Risankizumab Dose 2 (Sub-Study 1)Experimental Treatment1 Intervention

Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.

Group VI: Double-blind Risankizumab Dose 1 (Sub-Study 1)Experimental Treatment1 Intervention

Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.

Group VII: CTE: Open Label Continuous Treatment ExtensionExperimental Treatment1 Intervention

Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.

Group VIII: Double-blind Placebo for Risankizumab (Sub-Study 1)Placebo Group1 Intervention

Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

499,769 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

144,603 Total Patients Enrolled

Media Library

Risankizumab IV (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03105102 — Phase 3

Crohn's Disease Research Study Groups: Double-blind Risankizumab Dose 1 (Sub-Study 1), Maintenance Risankizumab Dose 2 (Sub-Study 2), Double-blind Placebo for Risankizumab (Sub-Study 1), Double-blind Risankizumab Dose 2 (Sub-Study 1), Maintenance Risankizumab Dose 1 (Sub-Study 2), Open-label Risankizumab (Sub-Study 3), Risankizumab On-Body Injector and Open Label (Sub-Study 4), CTE: Open Label Continuous Treatment Extension

Crohn's Disease Clinical Trial 2023: Risankizumab IV Highlights & Side Effects. Trial Name: NCT03105102 — Phase 3

Risankizumab IV (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03105102 — Phase 3

Frequently Asked Questions

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

Is it dangerous to use the Risankizumab On-Body Injector (OBI)?

"The safety of Risankizumab On-Body Injector (OBI) has been estimated to be a 3 by our team at Power. This is because it is a Phase 3 trial, meaning that there is data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

If a patient is above the age of 70, will they still be able to enroll in this program?

"This trial is only for patients aged 16 to 80. Out of the 303 total trials, 78 are designed specifically for minors and 225 are meant for adults over 65 years old."

Answered by AI

What are some of the common afflictions that Risankizumab On-Body Injector (OBI) has been shown to treat?

"The Risankizumab On-Body Injector (OBI) is a common treatment for dental plaque. It can also help patients manage psoriatic arthritis, skin disinfection therapy, and psoriasis."

Answered by AI

How many persons are eligible for this clinical research?

"This particular trial is no longer recruiting patients. The listing was created on April 9th, 2018 and edited for the last time on May 26th, 2022. However, there are currently 258 clinical trials related to Crohn's disease actively recruiting patients and 29 trials for Risankizumab On-Body Injector (OBI) that need participants."

Answered by AI

What does the current medical research say about Risankizumab On-Body Injector (OBI)?

"Currently, 29 clinical trials are underway to study the effects of Risankizumab On-Body Injector (OBI). Of these, 14 are in Phase 3. Most trials for Risankizumab On-Body Injector (OBI) are taking place Gdansk, Pomorskie; however, there are 3200 total locations running studies related to Risankizumab On-Body Injector (OBI)."

Answered by AI

Do you know of any hospitals in Canada that are participating in this clinical trial?

"At the moment, this clinical trial is enrolling at 100 hospitals, clinics and medical centres. 3 of these locations are in Mentor, Montreal and Houston with the other 97 sites located throughout various cities. If you want to ease travel burdens, try and select a site close to your location."

Answered by AI