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Monoclonal Antibodies

Risankizumab for Crohn's Disease

Q: What is the current enrollment of this clinical research trial?

Affirmative. Data posted on the clinicaltrials.gov website establishes that this scientific investigation is actively looking for participants, having been published on November 20th, 2023 and revised two days after. 276 people are required to be recruited from 5 distinct medical institutions.

Q: Has the FDA given its stamp of approval to Risankizumab Dose A within Period A?

The safety of Risankizumab Dose A has been assessed to be a 3 on the 1-3 scale due to its Phase 3 status, which implies that there is evidence in support of efficacy and numerous data points attesting to its security.

Q: Are multiple locations hosting this trial in the city?

Patients are being enrolled at five different medical centres. These include <a href="https://www.withpower.com/clinical-trials/louisiana">Louisiana</a> Research Center, LLC /ID# 256598 in Shreveport, Plains Clinical Research Center, LLC /ID# 256602 in Fargo and Southern Star Research Institute, LLC /ID# 256601 in San Antonio as well as two other clinical trial sites.

Q: Is it still feasible to join this investigation?

Per the information from clinicaltrials.gov, this trial is currently recruiting participants that meet its criteria. The initial post date was November 20th of 2023 and it has been recently updated on November 21st, 2023.

Q: What are the main goals of this trial?

This trial's principal goal, which will be assessed after 12 weeks, is to determine the percentage of participants that exhibit an endoscopic response. Secondary objectives include evaluating percentages of those with remission and ulcer-free endoscopy (based on SES-CD criteria) as well as determining changes in functional assessment of chronic illness therapy fatigue scores from baseline.

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Study Summary

This trial will assess the efficacy and safety of risankizumab SC treatment for adults with Crohn's disease, a long-lasting illness causing severe inflammation in the digestive tract.

Who is the study for?

Adults with moderately to severely active Crohn's Disease who haven't responded well to other treatments can join this study. They must have a confirmed diagnosis for at least 3 months and show clear signs of inflammation in their bowels.Check my eligibility

What is being tested?

The trial is testing Risankizumab, an approved drug for Crohn's Disease, given as a subcutaneous injection. Participants are randomly assigned to get either the real drug or a placebo during two periods, totaling about 49 weeks.See study design

What are the potential side effects?

Risankizumab may cause side effects such as infections, allergic reactions, headache, fatigue, skin problems like itching or rash, and potential injection site reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)

Percentage of Participants With Endoscopic Response

Secondary outcome measures

Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

Percentage of Participants With Clinical Remission

Percentage of Participants With Endoscopic Remission

+2 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Period B: Risankizumab Dose CExperimental Treatment1 Intervention

Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 20 weeks during Period B

Group II: Period B: Risankizumab Dose BExperimental Treatment1 Intervention

Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 20 weeks.

Group III: Period A: Risankizumab Dose AExperimental Treatment1 Intervention

Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.

Group IV: Period B: PlaceboPlacebo Group1 Intervention

Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo risankizumab administered by Subcutaneous (SC) injection for up to 20 weeks in Period B.

Group V: Period A: PlaceboPlacebo Group1 Intervention

Participants randomized to receive placebo risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,114 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,833 Total Patients Enrolled

Frequently Asked Questions

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

What is the current enrollment of this clinical research trial?

"Affirmative. Data posted on the clinicaltrials.gov website establishes that this scientific investigation is actively looking for participants, having been published on November 20th, 2023 and revised two days after. 276 people are required to be recruited from 5 distinct medical institutions."

Answered by AI

Has the FDA given its stamp of approval to Risankizumab Dose A within Period A?

"The safety of Risankizumab Dose A has been assessed to be a 3 on the 1-3 scale due to its Phase 3 status, which implies that there is evidence in support of efficacy and numerous data points attesting to its security."

Answered by AI

Are multiple locations hosting this trial in the city?

"Patients are being enrolled at five different medical centres. These include Louisiana Research Center, LLC /ID# 256598 in Shreveport, Plains Clinical Research Center, LLC /ID# 256602 in Fargo and Southern Star Research Institute, LLC /ID# 256601 in San Antonio as well as two other clinical trial sites."

Answered by AI

Is it still feasible to join this investigation?

"Per the information from clinicaltrials.gov, this trial is currently recruiting participants that meet its criteria. The initial post date was November 20th of 2023 and it has been recently updated on November 21st, 2023."

Answered by AI

What are the main goals of this trial?

"This trial's principal goal, which will be assessed after 12 weeks, is to determine the percentage of participants that exhibit an endoscopic response. Secondary objectives include evaluating percentages of those with remission and ulcer-free endoscopy (based on SES-CD criteria) as well as determining changes in functional assessment of chronic illness therapy fatigue scores from baseline."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

2023. "A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063967.

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