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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514695-41-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PK Cohort 1: SS1 | Experimental | 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 |
|
| PK Cohort 1: SS2 Dose A | Experimental | 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. |
|
| PK Cohort 1: SS2 Dose B | Experimental | 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. |
|
| PK Cohort 1: SS3 Dose A | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Risankizumab intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax) | Maximum observed plasma concentration (Cmax) | At Week 64 |
| PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax) | Maximum observed plasma concentration (Cmax) | At Week 64 |
| PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax) | Time to maximum plasma concentration (Tmax) | At Week 64 |
| PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax) | Time to maximum plasma concentration (Tmax) | 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) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Week 64 |
| PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital /ID# 273015 | Recruiting | Phoenix | Arizona | 85016 | United States | |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| PK Cohort 1: SS3 Dose B |
| Experimental |
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. |
|
| PK Cohort 2: SS1 | Experimental | 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. |
|
| PK Cohort 2: SS2 Dose A | Experimental | 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. |
|
| PK Cohort 2: SS2 Dose B | Experimental | 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. |
|
| PK Cohort 2: SS3 Dose A | Experimental | 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. |
|
| PK Cohort 2: SS3 Dose B | Experimental | 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. |
|
| Expansion Cohort 3: SS1 | Experimental | 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. |
|
| Expansion Cohort 3: SS2 Dose A | Experimental | 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. |
|
| Expansion Cohort 3: SS2 Dose B | Experimental | 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. |
|
| Expansion Cohort 3: SS3 Dose A | Experimental | 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. |
|
| Expansion Cohort 3: SS3 Dose B | Experimental | 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. |
|
| Risankizumab | Drug | Risankizumab subcutaneous (SC) injection |
|
|
| 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 | Up to 292 Weeks |
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 |
| 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 | 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 | 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. | 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. | At Week 12 |
| PK Lead-In Cohort 1: Achievement of endoscopic improvement | Endoscopic improvement defined as MES ≤ 1 | At Week 12 |
| PK Lead-In Cohort 2: Achievement of endoscopic improvement | Endoscopic improvement defined as MES ≤ 1 | 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. | 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. | 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. | 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. | At Week 64 |
| PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS | Endoscopic improvement defined as MES ≤ 1 | At Week 64 |
| PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS | Endoscopic improvement defined as MES ≤ 1 | 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 | 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 | Up to Week 64 |
| Expansion Cohort 3: Achievement of clinical remission per mMS | At Week 12 |
| Expansion Cohort 3: Achievement of clinical response per mMS | At Week 12 |
| Expansion Cohort 3: Achievement of endoscopic improvement | At Week 12 |
| Expansion Cohort 3: Symptomatic response per partial mMS | At Week 12 |
| Expansion Cohort 3: Achievement of clinical response per mMS among Week 12 responders per mMS | At Week 64 |
| Expansion Cohort 3: Achievement of endoscopic improvement among Week 12 responders per mMS | At Week 64 |
| Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS among Week 12 responders per mMS | At Week 64 |
| Rady Children's Hospital /ID# 271873 |
| Recruiting |
| San Diego |
| California |
| 92123 |
| United States |
| University of California San Francisco - Mission Bay /ID# 273022 | Recruiting | San Francisco | California | 94158 | United States |
| Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585 | Recruiting | Miami | Florida | 33155 | United States |
| Childrens Center For Digestive Health Care /ID# 273228 | Recruiting | Atlanta | Georgia | 30342 | United States |
| University of Chicago Medical Center /ID# 271588 | Recruiting | Chicago | Illinois | 60637 | United States |
| Goryeb Children's Hospital /ID# 271801 | Recruiting | Morristown | New Jersey | 07962 | United States |
| University Hospitals Cleveland Medical Center /ID# 271831 | Recruiting | Cleveland | Ohio | 44106 | United States |
| The Children's Hospital of Philadelphia /ID# 273222 | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Upmc Children'S Hospital Of Pittsburgh /ID# 272328 | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| Patewood Medical Campus /ID# 272477 | Recruiting | Greenville | South Carolina | 29615 | United States |
| Cliniques Universitaires UCL Saint-Luc /ID# 270123 | Recruiting | Brussels | Brussels Capital | 1200 | Belgium |
| Hospital Universite Enfants Reine Fabiola /ID# 271860 | Recruiting | Brussels | 1020 | Belgium |
| Centre Hospitalier Regional de la Citadelle /ID# 270459 | Recruiting | Liège | 4000 | Belgium |
| Galileo Medical Research /ID# 271817 | Recruiting | Juiz de Fora | Minas Gerais | 36033-318 | Brazil |
| Hospital Pequeno Príncipe /ID# 271814 | Recruiting | Curitiba | Paraná | 80250-060 | Brazil |
| Hospital Sirio Libanes - Sao Paulo /ID# 271818 | Recruiting | São Paulo | 01308-050 | Brazil |
| Alberta Children's Hospital /ID# 272635 | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
| Edmonton Clinic Health Academy /ID# 271168 | Recruiting | Edmonton | Alberta | T6G 1C9 | Canada |
| London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157 | Recruiting | London | Ontario | N6A 5W9 | Canada |
| Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023 | Recruiting | Cottbus | Brandenburg | 03048 | Germany |
| Klinikum Kassel /ID# 271546 | Recruiting | Kassel | Hesse | 34125 | Germany |
| Universitätsklinikum Münster - Albert Schweitzer Campus /ID# 271898 | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
| General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143 | Recruiting | Athens | Attica | 11527 | Greece |
| University General Hospital Attikon /ID# 272361 | Recruiting | Chaïdári | Attica | 12462 | Greece |
| General Hospital of Thessaloniki Hippokrateio /ID# 271939 | Recruiting | Thessaloniki | 54642 | Greece |
| Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889 | Recruiting | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895 | Recruiting | Naples | Napoli | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967 | Recruiting | Rome | Roma | 00168 | Italy |
| Ospedale Infantile Burlo Garofolo /ID# 274442 | Recruiting | Trieste | 34137 | Italy |
| Aichi Medical University Hospital /ID# 281613 | Not yet recruiting | Nagakute | Aichi-ken | 480-1195 | Japan |
| Kagawa University Hospital /ID# 282010 | Not yet recruiting | Kita-gun | Kagawa-ken | 761-0701 | Japan |
| Osaka Women's and Children's Hospital /ID# 280789 | Not yet recruiting | Izumi-Shi | Osaka | 594-1101 | Japan |
| Tokyo Medical University Hospital /ID# 280850 | Not yet recruiting | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Nagasaki University Hospital /ID# 281241 | Not yet recruiting | Nagasaki | 852-8501 | Japan |
| University Children's Hospital /ID# 269960 | Recruiting | Belgrade | Beograd | 11000 | Serbia |
| Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696 | Recruiting | Belgrade-Vračar | Beograd | 11000 | Serbia |
| Institute for Child and Youth Health Care of Vojvodina /ID# 269961 | Recruiting | Novi Sad | 21000 | Serbia |
| Pusan National University Yangsan Hospital /ID# 272769 | Recruiting | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Seoul National University Hospital /ID# 272852 | Recruiting | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Kangbuk Samsung Hospital /ID# 273333 | Recruiting | Seoul | Seoul Teugbyeolsi | 03181 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 272894 | Recruiting | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Samsung Medical Center /ID# 272862 | Recruiting | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Hospital Teresa Herrera - CHUAC /ID# 271459 | Recruiting | A Coruña | A Coruna | 15006 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466 | Recruiting | Majadahonda | Madrid | 28222 | Spain |
| Karolinska University Hospital Solna /ID# 271679 | Recruiting | Solna | Stockholm County | 171 64 | Sweden |
| Sodersjukhuset /ID# 271678 | Recruiting | Stockholm | Stockholm County | 118 83 | Sweden |
| Sahlgrenska Universitetssjukhuset /ID# 271675 | Recruiting | Gothenburg | Västra Götaland County | 413 46 | Sweden |
|
| Taichung Veterans General Hospital /ID# 269242 | Recruiting | Taichung | 407 | Taiwan |
| National Taiwan University Hospital /ID# 269244 | Recruiting | Taipei | 100 | Taiwan |
| Addenbrookes Hospital /ID# 271489 | Recruiting | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| Sheffield Children's Hospital NHS Foundation Trust /ID# 271490 | Recruiting | Sheffield | England | S10 2TH | United Kingdom |
| Alder Hey Children's NHS Foundation Trust /ID# 271533 | Recruiting | Liverpool | L12 2AP | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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