A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

Phase 3RecruitingNCT07071519

AbbVie120 enrolled

Overview

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. Adverse events and change in disease activity will be assessed. Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Interventions

RisankizumabDRUG

Risankizumab intravenous (IV) infusion

RisankizumabDRUG

Risankizumab subcutaneous (SC) injection

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. \- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available. Exclusion Criteria: * 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). * Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

Locations (65)

Phoenix Children's Hospital /ID# 273015

Phoenix, Arizona, United States

RECRUITING

Rady Children's Hospital /ID# 271873

San Diego, California, United States

RECRUITING

University of California San Francisco - Mission Bay /ID# 273022

San Francisco, California, United States

RECRUITING

Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue /ID# 271585

Miami, Florida, United States

Outcomes

Primary Outcomes

PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)

Maximum observed plasma concentration (Cmax)

Time frame: At Week 64

PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)

Maximum observed plasma concentration (Cmax)

Time frame: At Week 64

PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)

Time to maximum plasma concentration (Tmax)

Time frame: At Week 64

PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)

Time to maximum plasma concentration (Tmax)

Time frame: At Week 64

PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)

Area under the serum concentration-time curve over the dosing interval (AUCtau)

Time frame: At Week 64

PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)

Area under the serum concentration-time curve over the dosing interval (AUCtau)

Time frame: At Week 64

Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS

Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

Time frame: At Week 64

Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related

Time frame: Up to 292 Weeks

Secondary Outcomes

PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS

Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

Time frame: At Week 64

PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS

Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

Time frame: At Week 64

PK Lead-In Cohort 1: Achievement of clinical remission per mMS

Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

Time frame: At Week 12

PK Lead-In Cohort 2: Achievement of clinical remission per mMS

Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

Time frame: At Week 12

PK Lead-In Cohort 1: Achievement of clinical response per mMS

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.

Time frame: At Week 12

PK Lead-In Cohort 2: Achievement of clinical response per mMS

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.

Time frame: At Week 12

PK Lead-In Cohort 1: Achievement of endoscopic improvement

Central Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Childrens Center For Digestive Health Care /ID# 273228

Atlanta, Georgia, United States

RECRUITING

University of Chicago Medical Center /ID# 271588

Chicago, Illinois, United States

RECRUITING

Goryeb Children's Hospital /ID# 271801

Morristown, New Jersey, United States

RECRUITING

University Hospitals Cleveland Medical Center /ID# 271831

Cleveland, Ohio, United States

RECRUITING

The Children's Hospital of Philadelphia /ID# 273222

Philadelphia, Pennsylvania, United States

RECRUITING

Upmc Children'S Hospital Of Pittsburgh /ID# 272328

Pittsburgh, Pennsylvania, United States

RECRUITING

...and 55 more locations

Endoscopic improvement defined as MES ≤ 1

Time frame: At Week 12

PK Lead-In Cohort 2: Achievement of endoscopic improvement

Endoscopic improvement defined as MES ≤ 1

Time frame: At Week 12

PK Lead-In Cohort 1: Symptomatic response per partial mMS

Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.

Time frame: At Week 12

PK Lead-In Cohort 2: Symptomatic response per partial mMS

Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.

Time frame: At Week 12

PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.

Time frame: At Week 64

PK Lead-In Cohort 2: Achievement of clinical response per mMS among Week 12 responders per mMS

Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.

Time frame: At Week 64

PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS

Endoscopic improvement defined as MES ≤ 1

Time frame: At Week 64

PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS

Endoscopic improvement defined as MES ≤ 1

Time frame: At Week 64

PK Lead-In Cohort 1: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS

Time frame: Up to Week 64

PK Lead-In Cohort 2: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS

Time frame: Up to Week 64

Expansion Cohort 3: Achievement of clinical remission per mMS

Time frame: At Week 12

Expansion Cohort 3: Achievement of clinical response per mMS

Time frame: At Week 12

Expansion Cohort 3: Achievement of endoscopic improvement

Time frame: At Week 12

Expansion Cohort 3: Symptomatic response per partial mMS

Time frame: At Week 12

Expansion Cohort 3: Achievement of clinical response per mMS among Week 12 responders per mMS

Time frame: At Week 64

Expansion Cohort 3: Achievement of endoscopic improvement among Week 12 responders per mMS

Time frame: At Week 64

Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS among Week 12 responders per mMS

Time frame: At Week 64

A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

Overview

Conditions

Interventions

Eligibility

Locations (65)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts