A Phase 3 interventional study of Risankizumab and Risankizumab in Ulcerative Colitis, sponsored by AbbVie. Recruiting at 73 sites in 16 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting , 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 . Documentation of pathology results consistent with the diagnosis of UC must be available.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2
Drug: Risankizumab
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
Drug: Risankizumab
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
Drug: Risankizumab
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Drug: Risankizumab
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Drug: Risankizumab
Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Drug: Risankizumab
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.
Drug: Risankizumab
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.
Drug: Risankizumab
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Drug: Risankizumab
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Drug: Risankizumab
Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2.
Drug: Risankizumab
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
Drug: Risankizumab
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.
Drug: Risankizumab
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Drug: Risankizumab
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Drug: Risankizumab
Risankizumab intravenous (IV) infusion
Also known as: ABBV-066
Risankizumab subcutaneous (SC) injection
Also known as: ABBV-066
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
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
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
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
Started Jul 2025 (actual). Primary completion is estimated for Jul 2034, 108 months after the start.
Of 87 industry-sponsored phase 3 interventional studies under Colitis, Ulcerative, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 70. This study's planned 108 months is above that.
Counting every sponsor, half of 101 studies reached it within 48 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Risankizumab