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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

Study acronym: RISE
StatusRecruiting
PhasePhase 3
SponsorAbbVie
Started2023-12-11
View on ClinicalTrials.gov ↗
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. 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.

Amendment record

Amended 78 times since 2023-08-10; most recent filed 2026-05-27. The 50 most recent of 79 record versions are listed below. See every version on ClinicalTrials.gov ↗

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-05-27
Amendment Study Status, Contacts/Locations v78
2026-05-11
Amendment Study Status, Contacts/Locations v77
2026-03-16
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v76
2026-02-03
Amendment Study Status, Contacts/Locations v75
2025-09-26
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations, IPDSharing v74
2025-06-13
Amendment Study Status, Contacts/Locations v73
2025-05-05
Amendment Study Status v72
2025-04-30
Amendment Study Status, Contacts/Locations v71
2025-04-17
Amendment Study Status, Contacts/Locations v70
2025-04-10
Amendment Study Status, Contacts/Locations v69
2025-04-07
Amendment Study Status, Contacts/Locations v68
2025-03-25
Amendment Study Status, Contacts/Locations v67
2025-03-24
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2025-03-18
Amendment Study Status, Contacts/Locations v65
2025-03-12
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2025-03-03
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2025-02-27
Amendment Study Status v62
2025-02-21
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2025-02-14
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2025-01-20
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2025-01-17
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2025-01-13
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2025-01-03
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2025-01-02
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2024-12-27
Amendment Study Status, Contacts/Locations v54
2024-12-20
Amendment Study Status, Contacts/Locations v53
2024-12-03
Amendment Study Status, Contacts/Locations v52
2024-11-15
Amendment Study Status, Contacts/Locations v51
2024-11-06
Amendment Study Status v50
2024-10-29
Amendment Study Status, Contacts/Locations v49
2024-10-24
Amendment Study Status, Contacts/Locations v48
2024-10-18
Amendment Study Status, Contacts/Locations v47
2024-10-17
Amendment Study Identification, Study Status, Contacts/Locations v46
2024-10-10
Amendment Study Status, Contacts/Locations v45
2024-10-04
Amendment Study Status, Contacts/Locations v44
2024-10-02
Amendment Study Status v43
2024-09-30
Amendment Study Status, Contacts/Locations v42
2024-09-25
Amendment Study Status, Contacts/Locations v41
2024-08-23
Amendment Study Status, Contacts/Locations v40
2024-08-22
Amendment Study Status, Contacts/Locations v39
2024-08-19
Amendment Study Status, Contacts/Locations v38
2024-08-14
Amendment Study Status v37
2024-08-01
Amendment Study Status, Contacts/Locations v36
2024-07-30
Amendment Study Status, Contacts/Locations v35
2024-07-26
Amendment Study Status, Contacts/Locations v34
2024-07-25
Amendment Study Status, Contacts/Locations v33
2024-07-24
Amendment Study Status, Contacts/Locations v32
2024-07-17
Amendment Study Status, Contacts/Locations v31
2024-07-16
Amendment Study Status, Contacts/Locations v30
2024-07-10
Amendment Study Status, Contacts/Locations v29
Trial Details
NCT Number NCT05995353
Lead Sponsor AbbVie
Conditions Crohn's Disease
Enrollment 110 participants
Start Date 2023-12-11
Primary Completion 2029-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-29