Baricitinib in the Treatment of Intestinal Behçet's Syndrome

NCT06849908 | Recruiting Phase 2

• 1 other identifier: Baricitinib-IBS-PUMCH
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to conduct a randomized controlled trial to compare the efficacy and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS). The objective is to demonstrate if Baricitinib is non-inferior to ADA in controlling BS inflammation, reducing BS recurrence， alleviating gastrointestinal symptoms and promoting intestinal mucosal healing.

Conditions

Behcet Syndrome, Intestinal Type

Keywords

Baricitinib; Adalimumab; Intestinal Behçet's Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with marked improvement (MI) at week 24 of follow-up

  Based on the combined assessment of gastrointestinal symptoms and endoscopy scores\[1\], gastrointestinal symptom scoring is defined as follows: 0 points, asymptomatic; 1 point, does not affect daily life; 2 points, mildly affects daily life; 3 points, moderately affects daily life; 4 points, severely affects daily life. Endoscopy scoring is defined as follows: 0 points, mucosal healing; 1 point, maximum ulcer ≤ original 1/4; 2 points, maximum ulcer between original 1/4 and 1/2; 3 points, maximum ulcer ≥ original 1/2 or enlargement. Marked improvement is defined as gastrointestinal symptom and endoscopy scores both ≤ 1. \[1\]Sugimura, N. et al. Real-world efficacy of adalimumab and infliximab for refractory intestinal Behçet's disease. Dig. Liver Dis. 51, 967-971 (2019).

  Baseline to week 24

Secondary Outcomes (9)

• Proportion of patients with CR (complete response) at week 24 of follow-up

  Baseline to week 24

• Proportion of patients with improvement of ≥1 point in gastrointestinal symptom scores compared to baseline at week 24 of follow-up

  Baseline to week 24

• Changes in C-reactive protein (CRP) compared to baseline

  Baseline to week 24

• Changes in erythrocyte sedimentation rate (ESR) compared to baseline

  Baseline to week 24

• Changes in DAIBD scores compared to baseline

  Baseline to week 24

Study Arms (2)

Baricitinib for IBS

EXPERIMENTAL

Drug: Baricitinib

Adalimumab for IBS

EXPERIMENTAL

Drug: Adalimumab

Interventions

Baricitinib DRUG

Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with Baricitinib 4 mg/day for 6 months.

Also known as: Olumiant®

Baricitinib for IBS

Adalimumab DRUG

Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with ADA (initially ADA 160 mg subcutaneous injection, followed by 80 mg ADA after 2 weeks, then 40 mg ADA every 2 weeks thereafter) for 6 months.

Also known as: Humira®

Adalimumab for IBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refer to the consensus on the diagnosis and treatment of intestinal Behçet's syndrome in China: Patients who meet the 2013 International Criteria for Behçet's Disease (ICBD) and have typical Behçet's syndrome-related intestinal ulcers confirmed by colonoscopy, or patients diagnosed according to the criteria for Behçet's syndrome established by the Korean Behçet's Disease Collaborative Group in 2009;
• Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline;
• Patients who have been treated with medium to high-dose steroids (prednisolone equivalent of 0.5-1 mg/kg/day) for more than 1 month continuously, or any immunomodulator/Immunosuppressants for more than 3 months regularly or biologics for more than 2 months, as judged by the doctor to be treatment failure or intolerance;
• Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks;
• Understanding the research process, voluntary participation, and signing of informed consent.

You may not qualify if:

• Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.;
• Other active organ damage related to BS requires intensified immunosuppressive therapy, including aneurysms, uveitis, and substantial involvement of the central nervous system; skin lesions and joint involvement can be included;
• Severe organ dysfunction including ALT, AST, TBIL levels exceeding twice the upper limit of normal, creatinine levels exceeding 1.5 times the upper limit of normal, white blood cell count \< 3×10\^9/L, ANC \< 2×10\^9/L, hemoglobin \< 80g/L, platelets \< 100×10\^9/L;
• Active infections such as active tuberculosis, active hepatitis B or C, syphilis, chronic Epstein-Barr virus infection, HIV infection, sustained or severe bacterial or viral infections, and history of severe herpes zoster;
• Primary immunodeficiency disease;
• History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies;
• Patients who did not respond to infliximab treatment for primary refractory BS (patients with secondary failure, intolerance, or allergy to infliximab should be included);
• Patients treated with biologics/small molecule targeting therapies within 5 half-lives (including use of tofacitinib within 10 days, etanercept within 4 weeks, infliximab within 8 weeks, golimumab, certolizumab, abatacept, and tocilizumab within 10 weeks, ustekinumab within 6 months);
• Patients with prior use of baricitinib or ADA;
• Complications of intestinal BS such as symptomatic stenosis, short bowel syndrome, intestinal fistula, or suspected intra-abdominal abscess; potential need for surgery or situations not conducive to DAIBD and efficacy assessment; any form of intestinal resection or other abdominal surgery within 6 months before baseline; presence of a functioning (i.e., patent) stoma or ostomy;
• Patients requiring parenteral nutrition due to disease severity;
• Pregnant, lactating, or planning pregnancy soon;
• Patients unwilling or unable to comply with regular visits;
• History of severe thrombotic events or chronic cardiovascular events.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Behcet Syndrome

Interventions

baricitinib; Adalimumab

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jinjing Liu, M.D.

CONTACT

86-10-69151188; pumch_followup@126.com

Wenjie Zheng, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: February 27, 2025
• Study Start: November 8, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)