NCT04524611: SEQUENCE

A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

Active, enrolled Phase 3 Last updated 9 April 2026

What this trial tests

Phase 3 trial testing Risankizumab in Crohn's Disease (CD) in 527 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 September 2020

Primary endpoint
1 February 2028

1 February 2028

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	527
Start date	30 September 2020
Primary completion	1 February 2028
Estimated completion	1 February 2028
Sites	300 locations across United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

Drugs / interventions tested

• Risankizumab (RISANKIZUMAB) — full drug profile →
• Risankizumab (RISANKIZUMAB) — full drug profile →
• Ustekinumab (ustekinumab) — full drug profile →
• Ustekinumab (ustekinumab) — full drug profile →

Conditions studied

• Crohn's Disease (CD) — all drugs for Crohn's Disease (CD) →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 80, any sex, with Crohn's Disease (CD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants Achieving Clinical Remission at Week 24
  Time frame: Week 24
  Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
• Percentage of Participants Achieving Endoscopic Remission
  Time frame: Week 48
  Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
• Number of Participants Reporting Adverse Events
  Time frame: Up to 220 Weeks
  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requ

Sponsor's own description

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis.
   Singh S, Murad MH, Fumery M, Sedano R, et al · · 2021 · cited 223× · PMID 34688373 · DOI 10.1016/s2468-1253(21)00312-5
2. Approach to the Management of Recently Diagnosed Inflammatory Bowel Disease Patients: A User's Guide for Adult and Pediatric Gastroenterologists.
   Agrawal M, Spencer EA, Colombel JF, Ungaro RC. · · 2021 · cited 183× · PMID 33940007 · DOI 10.1053/j.gastro.2021.04.063
3. IL-12 and IL-23 pathway inhibition in inflammatory bowel disease.
   Verstockt B, Salas A, Sands BE, Abraham C, et al · · 2023 · cited 167× · PMID 37069321 · DOI 10.1038/s41575-023-00768-1
4. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease.
   Peyrin-Biroulet L, Chapman JC, Colombel JF, Caprioli F, et al · · 2024 · cited 122× · PMID 39018531 · DOI 10.1056/nejmoa2314585
5. Targeted Immunotherapy for Autoimmune Disease.
   Jung SM, Kim WU. · · 2022 · cited 113× · PMID 35291650 · DOI 10.4110/in.2022.22.e9
6. Inflammatory Bowel Disease-Associated Colorectal Cancer: Translational Risks from Mechanisms to Medicines.
   Porter RJ, Arends MJ, Churchhouse AMD, Din S. · · 2021 · cited 103× · PMID 34111282 · DOI 10.1093/ecco-jcc/jjab102
7. Blockade of IL-23: What is in the Pipeline?
   Parigi TL, Iacucci M, Ghosh S. · · 2022 · cited 74× · PMID 35553666 · DOI 10.1093/ecco-jcc/jjab185
8. Risankizumab: Mechanism of action, clinical and translational science.
   Pang Y, D'Cunha R, Winzenborg I, Veldman G, et al · · 2024 · cited 26× · PMID 38266061 · DOI 10.1111/cts.13706