臨床研究等提出・公開システム

[M23-784] A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease

[M23-784] A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Otani Tetsuya

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

May. 01, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Participant meets the following disease activity criteria:
1. Moderate to severe CD
2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
- Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.

- Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participants with unstable doses of concomitant Crohn's disease therapy.
- Participants with prior exposure to p19 inhibitors.
- Participants with complications of Crohn's disease.
- Participants having an ostomy or ileoanal pouch.

Both

Crohn's Disease

Period A: Risankizumab Dose A or Pracebo
Participants randomized to receive risankizumab Dose A or placebo risankizumab administered by subcutaneous (SC) injection for up to 12 weeks during Period A.

Period B: Risankizumab Dose B or Pracebo or Risankizumab Dose C
Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 20 weeks.
Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo risankizumab administered by Subcutaneous (SC) injection for up to 20 weeks in Period B.
Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 20 weeks during Period B.

- Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150) (Time Frame: Week 12)
- Percentage of Participants With Endoscopic Response (Time Frame: Week 12)

- Percentage of Participants With SF / APS Clinical Remission (Time Frame: Week 12)
- Percentage of Participants With Endoscopic Remission (Time Frame: Week 12)
- Percentage of Participants With Ulcer-Free Endoscopy (Time Frame: Week 12)
- Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (Time Frame: Week 12)
- Percentage of Participants with a CR-100 Clinical Response (Time Frame: Week 4)

Feb. 16, 2024

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

United States/Canada/Israel/Taiwan