RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Risankizumab for Ulcerative Colitis

Q: Is NCT07071519 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07071519?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07071519?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC.

Official registry: https://clinicaltrials.gov/study/NCT07071519 · AbbVie · enrollment listed as 120

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Risankizumab, or Risankizumab. The registry lists allocation as randomized. Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).

They plan to enroll about 120 people at 73 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Interventions: Risankizumab, Risankizumab

Primary outcome (registry wording): PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)

Who it is for (from inclusion criteria)

Ages 2 Years to 17 Years
Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader)
Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:
aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol

Who the registry excludes

Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection)

Public study contact (from the registry)

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

73 listed

Phoenix Children's Hospital /ID# 273015 — Phoenix, Arizona (recruiting)
Rady Children's Hospital /ID# 271873 — San Diego, California (recruiting)
University of California San Francisco - Mission Bay /ID# 273022 — San Francisco, California (recruiting)
Nicklaus Children's Hospital - Miami /ID# 271585 — Miami, Florida (recruiting)
Childrens Center For Digestive Health Care /ID# 273228 — Atlanta, Georgia (recruiting)
University of Chicago Medical Center /ID# 271588 — Chicago, Illinois (recruiting)
Goryeb Children's Hospital /ID# 271801 — Morristown, New Jersey (recruiting)
University Hospitals Cleveland Medical Center /ID# 271831 — Cleveland, Ohio (recruiting)
The Children's Hospital of Philadelphia /ID# 273222 — Philadelphia, Pennsylvania (recruiting)
Upmc Children'S Hospital Of Pittsburgh /ID# 272328 — Pittsburgh, Pennsylvania (recruiting)
Patewood Medical Campus /ID# 272477 — Greenville, South Carolina (recruiting)
University of Texas - Southwestern Medical Center /ID# 271835 — Dallas, Texas (recruiting)

+ 61 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07071519 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07071519?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07071519?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary