Who may be eligible for the Baricitinib in the Treatment of Intestinal Behçet's Syndrome trial?

Inclusion Criteria: 1. 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; 2. Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline; 3. Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers; 4. 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; 5. Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks; 6. Understanding the research process, voluntary participation, and signing of informed consent. Exclusion Criteria: 1. Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.; 2. 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; 3. 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; 4. 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; 5. Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion; 6. Primary immunodeficiency disease; 7. History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies; 8. Patients who did not respond to infliximab treatment for primary refractory BS (patients with secondary failure, intolerance, or allergy to infliximab should be included); 9. 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); 10. Patients with prior use of baricitinib or ADA; 11. 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; 12. Patients requiring parenteral nutrition due to disease severity; 13. Pregnant, lactating, or planning pregnancy soon; 14. Patients unwilling or unable to comply with regular visits; 15. History of severe thrombotic events or chronic cardiovascular events.

ClinicalTrials.gov record NCT06849908

Baricitinib in the Treatment of Intestinal Behçet's Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Refractory Intestinal Behçet's Syndrome Patients

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old to 65 years old

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 randomized, open-label study compares baricitinib with adalimumab in adults with refractory intestinal Behçet's syndrome. Participants keep their current steroids or immunomodulators and receive either baricitinib 4 mg daily or adalimumab injections for 6 months. Outcomes include symptom and endoscopy assessments, inflammatory markers, quality-of-life measures, and adverse events through week 24.

What it is studying. Whether baricitinib is non-inferior to adalimumab for controlling intestinal inflammation, improving symptoms, and promoting intestinal mucosal healing in refractory intestinal Behçet's syndrome.

What the researchers hope to learn. To test non-inferiority of baricitinib versus adalimumab for marked improvement at week 24, and to measure complete response rates, changes in symptom scores, inflammatory markers (CRP, ESR), disease activity indexes (DAIBD, BDCAF), quality-of-life scores (SF-36, IBDQ), and the incidence of treatment-emergent adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Baricitinib
Adalimumab

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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;
Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers;
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.

Exclusion criteria

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;
Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion;
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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The non-inferiority will be established by comparing the lower bound of the two-sided 95% confidence interval with the non-inferiority margin. If the lower bound was larger than the margin, Baricitinib would be regarded as non-inferiror to ADA. Superority will be further assessed in case that the non-inferiority is established. Both ITT and PP analysis will be conducted for the primary outcome given the non-inferiority design. Trial result will be primarily interpreted based on ITT analysis.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned to one of two 6-month treatment groups: oral baricitinib 4 mg/day while keeping their current steroids and/or immunomodulators, or subcutaneous adalimumab given as 160 mg initially, 80 mg at 2 weeks, then 40 mg every 2 weeks while keeping current medications. They are followed for 24 weeks with assessments of gastrointestinal symptoms, endoscopic exams (colonoscopy) to check intestinal ulcers, blood tests for inflammatory markers (CRP and ESR), disease-activity scores (DAIBD, BDCAF), and quality-of-life questionnaires (SF-36, IBDQ). The study team will monitor and record any side effects or adverse events throughout the study. Exact visit timing and other procedure details are provided by the study staff.

How the study is structured. Randomized, open-label, parallel-group Phase 2 trial with two drug arms. One arm receives oral baricitinib 4 mg daily plus their existing steroids/immunomodulators; the other receives adalimumab (160 mg initial subcutaneous dose, 80 mg at week 2, then 40 mg every 2 weeks) plus existing therapy, for six months. The main outcome is assessed at week 24 using combined gastrointestinal symptom and endoscopy scores. The study is not masked.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Behcet Syndrome, Intestinal Type. Does it apply to my diagnosis?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

This trial is also listed on this site under Behçet's disease.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 8, 2024
Primary completion: Jun 30, 2027 (estimated)
Study completion: Jun 30, 2028 (estimated)
Target enrollment: 56 participants (estimated)
Last updated on registry: Sep 21, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Peking Union Medical College Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Jinjing Liu, M.D. 📞 86-10-69151188 ✉ pumch_followup@126.com
Wenjie Zheng, M.D.

Participating sites (2)

Peking Union Medical College HospitalNot Yet Recruiting
Beijing, Beijing Municipality, 100730 · China
- Wenjie Zheng, M.D.
Peking Union Medical College HospitalRecruiting
Beijing · China
- Jinjing Liu · 86-10-69151188 · pumch_followup@126.com

Terms used on this page · explanations by MedicalUpdates.ai

randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
prednisolone: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Immunosuppressants: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
ANC: The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
5 half-lives: The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
non-inferiority: What a comparison is designed to show. A superiority study asks whether the new treatment is better than the comparator; a non-inferiority study asks whether it is not meaningfully worse.
primary outcome: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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