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Clinical Trials List

Protocol NumberM24-885

NCT Number(ClinicalTrials.gov Identfier)NCT06548542

Active

2025-08-01 - 2030-04-30

Phase II

Recruiting4

ICD-10K50.00

Crohn's disease of small intestine without complications

ICD-10K50.011

Crohn's disease of small intestine with rectal bleeding

ICD-10K50.018

Crohn's disease of small intestine with other complication

ICD-10K50.019

Crohn's disease of small intestine with unspecified complications

ICD-9555.0

Regional enteritis, small intestine

A phase 2a, multicenter, randomized, plateau trial of targeted therapy in adult subjects with moderate to severe Crohn's disease.

Trial Applicant

AbbVie
Sponsor

AbbVie Pharmaceuticals Ltd. Taiwan Branch
Trial scale

Multi-Regional Multi-Center
Update

2026/07/22

Investigators and Locations

Principal Investigator SHU-CHEN WEI Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

謝銘鈞 Digestive System Department
YEN-HSUAN NI Division of Pediatrics
翁孟慈 Digestive System Department
Huey-Ling Chen Division of Pediatrics
吳嘉峯 Division of Pediatrics
吳心耘 Digestive System Department
陳知澈 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jiing-Chyuan Luo Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

李癸汌 Digestive System Department
Chun-Chi Lin Division of General Internal Medicine
Hung-Hsin Lin Division of General Internal Medicine
張天恩 Division of General Internal Medicine
吳佩珊 Division of General Internal Medicine
陳宥任 Digestive System Department
呂學聖 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Wei Chou Digestive System Department

China Medical University Hospital

Co-Principal Investigator

Chun-Lung Feng Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Puo-Hsien Le

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

許振銘 Digestive System Department
Chia-Jung Kuo
Cheng-Tang Chiu Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Moderate to severe Crohn's disease

Objectives

Crohn's disease (CD) is a chronic condition that causes severe inflammation (redness, swelling) of the digestive tract, most commonly affecting the gut. It can cause a variety of symptoms, including abdominal pain, diarrhea, fatigue, and weight loss. While treatments are available, their effectiveness varies among patients or may become ineffective over time. This study will evaluate the efficacy and adverse events of targeted therapies (TaTs) in adult participants with moderate to severe Crohn's disease.

Test Drug

ABBV-8736
Lutikizumab (ABT-981)
risankizumab
Trosunilimab (ABBV- 382)

Active Ingredient

ABBV-8736
Lutikizumab (ABT-981)
risankizumab
Trosunilimab (ABBV- 382)

Dosage Form

N/A
N/A
N/A
N/A

Dosage

N/A

Endpoints

Endoscopic relief was achieved at week 12.

Inclution Criteria

- The subject's baseline weight must be ≥40 kg.

- A diagnosis of Crohn's disease (CD) must have been made at least 3 months prior to the baseline. A biopsy record must be available, assessed by the trial administrator as meeting the diagnostic criteria for CD.

- A CDAI score ≥220 at the baseline.

- Endoscopic evidence of mucosal inflammation, supported by an ileocolic or colonic disease SES-CD ≥6 or isolated ileal disease SES-CD ≥4. All qualifying scores exclude the presence of strictures and are confirmed by a central interpreter.

- The subject must demonstrate poor tolerance or response to targeted therapies (TaTs), including biologics.

Exclusion Criteria

- Subjects with poor tolerance to p19 inhibitors (including risankizumab).

- Subjects who received any investigational TaT (or obtained approval for a TaT during the trial) within 30 days or 5 half-lives prior to the baseline period, whichever is longer. Note: If records show that the concentration of any of the above-mentioned approved biologics was undetectable (or below the limit of quantitation/quantitation) by commercially available analytical methods, there is no minimum clearance period prior to the baseline period.

- Subjects meeting any of the following criteria: currently diagnosed with UC or indeterminate colitis; currently known to have Crohn's disease complications, such as: currently having a colostomy or ileoanal anastomotic pouch; or having undergone bowel resection within 3 months prior to the baseline period.

The Estimated Number of Participants

Taiwan

12 participants
Global

840 participants