Crohn's DiseasePhase 3RISENCT05995353
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Risankizumab in people with Crohn's Disease, run by AbbVie at 85 sites in 21 countries.
Trial summary
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 85 sitesin 21 countries
- Study dates
- 11 Dec 2023to Apr 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric individuals, 2 to < 18 years old
- Must have moderately to severely active CD, as defined by the PCDAI score > 30 assessed at Baseline
- Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)
- Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies
Who cannot join
- History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class
- Any of the following medical disorders:
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
- A diagnosis of CD prior to 2 years of age.
- A diagnosis or suspected diagnosis of a primary immunodeficiency.
- Currently known complications of CD such as:
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- Active abscess (abdominal or perianal);
- Symptomatic bowel strictures;
- > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
- Fulminant colitis;
- Toxic megacolon;
- Or any other manifestation that might require surgery while enrolled in the study.
- Ostomy or ileoanal pouch.
- Diagnosis of short gut or short bowel syndrome.
- Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of >3 bowel resections.
Trial locations and contacts
85 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
85 sites in 21 countries
United States11 sites, 10 recruiting
- Recruiting
Children's Hospital Colorado - Aurora /ID# 255764
Aurora, Colorado, 80045
- Recruiting
Cleveland Clinic - Cleveland /ID# 256453
Cleveland, Ohio, 44195
Site Coordinator, 216-636-2007
- Recruiting
Indiana University Health Riley Hospital for Children /ID# 256454
Indianapolis, Indiana, 46202
- Completed
Arkansas Children's Hospital /ID# 255762
Little Rock, Arkansas, 72202
- Recruiting
MNGI Digestive Health, P. A. /ID# 255366
Minneapolis, Minnesota, 55413-2195
- Recruiting
Goryeb Childrens Hospital /ID# 256452
Morristown, New Jersey, 07960
- Recruiting
Icahn School of Medicine at Mount Sinai /ID# 254880
New York, New York, 10029
- Recruiting
UCSF Benioff Children's Hospital - Oakland /ID# 258327
Oakland, California, 94609
- Recruiting
Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
Orlando, Florida, 32806-1141
- Recruiting
Phoenix Children's Hospital /ID# 255766
Phoenix, Arizona, 85016-7710
- Recruiting
Massachusetts General Hospital - Mass General Waltham /ID# 255767
Waltham, Massachusetts, 02451
China10 sites, 10 recruiting
- Recruiting
Beijing Children's Hospital /ID# 256081
Beijing, Beijing Municipality, 100045
- Recruiting
Peking University Third Hospital /ID# 255876
Beijing, Beijing Municipality, 100191
Site Coordinator, +86 010-82266699
- Recruiting
Hunan Children's Hospital /ID# 255610
Changsha, Hunan, 410007
- Recruiting
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428
Guangzhou, Guangdong, 510620
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589
Guangzhou, Guangdong, 510655
- Recruiting
Jiangxi Provincial Children's Hospital /ID# 255564
Nanchang, Jiangxi, 330006
- Recruiting
Children's Hospital of Shanghai /ID# 255531
Shanghai, Shanghai Municipality, 200062
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688
Shanghai, Shanghai Municipality, 200065
- Recruiting
Shengjing Hospital of China Medical University /ID# 255563
Shenyang, Liaoning, 110022
- Recruiting
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562
Zhengzhou, Henan, 450018
Japan10 sites, 10 recruiting
- Recruiting
Institute of Science Tokyo Hospital /ID# 269175
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
Tokyo Metropolitan Children's Medical Center /ID# 268415
Fuchu-shi, Tokyo, 183-8561
- Recruiting
Osaka Women's and Children's Hospital /ID# 268419
Izumi-Shi, Osaka, 594-1101
- Recruiting
Tsujinaka Hospital - Kashiwanoha /ID# 268409
Kashiwa-shi, Chiba, 277-0871
- Recruiting
Japanese Red Cross Kumamoto Hospital /ID# 268586
Kumamoto, Kumamoto, 861-8520
- Recruiting
Kurume University Hospital /ID# 268418
Kurume-shi, Fukuoka, 830-0011
- Recruiting
Gunma University Hospital /ID# 270560
Maebashi, Gunma, 371-8511
- Recruiting
Aichi Children's Health And Medical Center /ID# 272085
Ōbu, Aichi-ken, 474-8710
- Recruiting
Saitama Children's Medical Center /ID# 268410
Saitama-shi, Saitama, 330-8777
- Recruiting
National Center For Child Health And Development /ID# 268420
Setagaya City, Tokyo, 157-8535
Belgium6 sites, 6 recruiting
- Recruiting
Cliniques Universitaires UCL Saint-Luc /ID# 255108
Brussels, Brussels Capital, 1200
- Recruiting
Hospital Universite Enfants Reine Fabiola /ID# 255112
Brussels, 1020
- Recruiting
Uza /Id# 255114
Edegem, Antwerpen, 2650
- Recruiting
Universitair Ziekenhuis Brussel /ID# 255109
Jette, Brussels Capital, 1090
- Recruiting
Universitair Ziekenhuis Leuven /ID# 255098
Leuven, Vlaams-Brabant, 3000
- Recruiting
Groupe Sante CHC - Clinique du MontLegia /ID# 255620
Liège, 4000
France5 sites, 5 recruiting
- Recruiting
Chu Bordeaux - Hopital Pellegrin /ID# 257060
Bordeaux, New Aquitaine, 33076
- Recruiting
Hospices Civils de Lyon - Hopital Femme Mere Enfant /ID# 255443
Bron, Rhone, 69500
- Recruiting
AP-HP - Hopital Necker /ID# 255608
Paris, 75015
- Recruiting
CHU Toulouse - Hopital Paule de Viguier /ID# 255609
Toulouse, Occitanie, 31059
- Recruiting
CHRU Tours - Hopital Gatien de Clocheville /ID# 255052
Tours, Centre-Val de Loire, 37044
Canada4 sites, 4 recruiting
- Recruiting
Alberta Children's Hospital /ID# 255357
Calgary, Alberta, T3B 6A8
- Recruiting
Edmonton Clinic Health Academy /ID# 255361
Edmonton, Alberta, T6G 1C9
- Recruiting
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598
London, Ontario, N6A 5W9
- Recruiting
BC Children's Hospital /ID# 255359
Vancouver, British Columbia, V6H 3V4
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Istituto Giannina Gaslini /ID# 255262
Genoa, Genova, 16147
- Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044
Messina, 98125
- Recruiting
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045
Naples, Napoli, 80131
- Recruiting
Ospedale Pediatrico Bambino Gesu /ID# 255043
Rome, Roma, 00165
South Korea4 sites, 4 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital /ID# 255817
Daegu, 41404
- Recruiting
Seoul National University Hospital /ID# 255318
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Yonsei University Health System - Severance Hospital /ID# 256976
Seoul, Seoul Teugbyeolsi, 03722
- Recruiting
Samsung Medical Center /ID# 255284
Seoul, Seoul Teugbyeolsi, 06351
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Gazi University Medical Faculty /ID# 255086
Ankara, 06560
- Recruiting
Sariyer Hamidiye Etfal Egitim Ve Araştirma Hastanesi /ID# 257143
Istanbul, 34453
- Recruiting
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020
Istanbul, 34899
- Recruiting
Kocaeli University Med Faculty /ID# 256922
Kocaeli, 41380
Bulgaria3 sites, 2 recruiting
- Recruiting
UMHAT Sveti Georgi EAD /ID# 255386
Plovdiv, 4002
- Completed
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384
Sofia, 1606
- Recruiting
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358
Varna, 9009
Spain3 sites, 2 recruiting
- Recruiting
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614
Ferrol, A Coruna, 15405
- Completed
Hospital Infantil Universitario Nino Jesus /ID# 255012
Madrid, 28009
- Recruiting
Hospital Regional Universitario de Malaga /ID# 257553
Málaga, 29011
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset /ID# 255236
Gothenburg, Västra Götaland County, 413 46
Site Coordinator, +46313435865
- Recruiting
Sodersjukhuset /ID# 255239
Stockholm, Stockholm County, 118 83
- Recruiting
Astrid Lindgrens Barnsjukhus /ID# 255240
Stockholm, Stockholm County, 171 76
United Kingdom3 sites, 3 recruiting
- Recruiting
Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
Birmingham, B4 6NH
- Recruiting
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
London, Greater London, E1 2ES
- Recruiting
Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
Sheffield, England, S10 2TH
Site Coordinator, +44 114 273 0522
Czechia2 sites
- Completed
Vseobecna Fakultni nemocnice v Praze /ID# 256096
Prague, Praha 17, 128 00
- Completed
Fakultni nemocnice Motol a Homolka /ID# 256547
Prague, Praha 5, 150 06
Germany2 sites, 2 recruiting
- Recruiting
Dr. von Haunerschen Kinderspital /ID# 255577
Munich, Bavaria, 80337
- Recruiting
Universitaetsklinikum Muenster /ID# 256762
Münster, North Rhine-Westphalia, 48149
Israel2 sites, 2 recruiting
- Recruiting
Shaare Zedek Medical Center /ID# 254951
Jerusalem, Jerusalem, 91031
- Recruiting
Schneider Children's Medical Center /ID# 254950
Petah Tikva, Central District, 4920235
Poland2 sites, 1 recruiting
- Completed
Gastromed Sp. z o.o /ID# 255939
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
- Recruiting
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938
Warsaw, Masovian Voivodeship, 04-730
Puerto Rico2 sites, 2 recruiting
- Recruiting
Puerto Rico Health Institute /ID# 255071
Dorado, 00646
- Recruiting
Clinical Research Puerto Rico /ID# 266479
San Juan, 00909-1711
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital, Universitaetsspital Bern /ID# 255321
Bern, 3010
- Recruiting
Kinderspital Zurich - Eleonorenstiftung /ID# 255337
Zurich, Canton of Zurich, 8032
Taiwan2 sites, 2 recruiting
- Recruiting
Changhua Christian Hospital /ID# 256082
Changhua City, Changhua County, 50006
- Recruiting
National Taiwan University Hospital /ID# 255679
Taipei, 100
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center /ID# 254827
Amsterdam, North Holland, 1105 AZ
About this study
Official title: A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to other therapies.
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD 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 induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 sites worldwide.
Read more
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.
- Conditions
- Crohn's Disease
- Being tested
- Risankizumab
- Keywords
- Crohn's Disease, Risankizumab, Skyrizi, Pediatrics
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Also called ABBV-066, SKYRIZI
Intravenous (IV) Infusion
RisankizumabDrug
Also called ABBV-066, SKYRIZI
Subcutaneous (SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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 subjects who complete SS1 are eligible to enter SS2. Receives: Drug: Risankizumab |
| 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 either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3. Receives: Drug: Risankizumab |
| 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 either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
| 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. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Measured: At 64 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Measured: At 64 weeks
Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
Cmax of risankizumab
Measured: Up to approximately Week 64
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
Tmax of risankizumab
Measured: Up to approximately 64 weeks
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
AUCtau of risankizumab
Measured: Up to approximately 64 weeks
Secondary outcomes (12)
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Measured: At 12 weeks
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Measured: At 12 weeks
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
Measured: At 12 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
Measured: At 64 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
Measured: At 64 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Measured: At 64 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Measured: At 64 weeks
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Measured: At 12 weeks
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Measured: At 12 weeks
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
Measured: At 12 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader.
Measured: At 64 weeks
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
Measured: At 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start11 Dec 2023
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995353
- Sponsor's protocol ID
- M16-194
- Other IDs
- 2022-502050-14-00
- Acronym
- RISE
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.