Behcet Syndrome, Intestinal TypePhase 2NCT06849908
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
A Phase 2 study testing Baricitinib and Adalimumab in people with Behcet Syndrome, Intestinal Type, run by Peking Union Medical College Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Behcet Syndrome, Intestinal Type
- What is being tested?
- Baricitinib and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesChina
- Study dates
- 8 Nov 2024to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wenjie Zheng, M.D. contact
China2 sites, 2 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wenjie Zheng, M.D.
- Recruiting
Peking Union Medical College Hospital
Beijing
Jinjing Liu, 86-10-69151188, pumch_followup@126.com
About this study
Official title: A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Refractory Intestinal Behçet's Syndrome Patients
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.
Read the detailed description
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.
- Conditions
- Behcet Syndrome, Intestinal Type
- Being tested
- Baricitinib, Adalimumab
- Keywords
- Baricitinib, Adalimumab, Intestinal Behçet's Syndrome
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Olumiant®
Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with Baricitinib 4 mg/day for 6 months.
AdalimumabDrug
Also called Humira®
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.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib for IBS | Experimental | Not described Receives: Drug: Baricitinib |
| Adalimumab for IBS | Experimental | Not described Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to week 24
Secondary outcomes (9)
Proportion of patients with CR (complete response) at week 24 of follow-up
CR is defined as both gastrointestinal symptoms and endoscopy scores being 0.
Measured: 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
Measured: Baseline to week 24
Changes in C-reactive protein (CRP) compared to baseline
The hs-CRP is acute phase reactants that are indicative of the patient's disease activity.
Measured: Baseline to week 24
Changes in erythrocyte sedimentation rate (ESR) compared to baseline
The ESR is acute phase reactants that are indicative of the patient's disease activity.
Measured: Baseline to week 24
Changes in DAIBD scores compared to baseline
Disease Activity Index for Intestinal Behcet's Disease (DAIBD)；
Measured: Baseline to week 24
Changes in BDCAF scores compared to baseline
Behçet's Disease Current Activity Index (BDCAF)；
Measured: Baseline to week 24
Changes in SF-36 of life questionnaires compared to baseline
Short Form (36) Health Survey(SF-36);
Measured: Baseline to week 24
Changes in IBDQ quality of life questionnaires compared to baseline
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: Baseline to week 24
Incidence of Treatment-Emergent Adverse Events
Record the types, frequency, and severity of adverse events, as well as the number of study participants who were drop out due to any adverse events. Adverse event: Any medical condition that affects the health of the participant during the study or worsens a preexisting medical condition, regardless of whether it is causally related to the study, is considered an adverse event.
This can be symptoms, signs, or abnormal laboratory tests. Serious adverse event (SAE): Any significant medical event that causes death, is life-threatening, requires hospitalization, results in permanent or severe disability or loss of function, or the investigator deems it a significant medical event that may seriously harm the participant or require medical intervention to prevent the above outcomes.
The causal relationship between the serious adverse event and the study is determined by the investigator's discussion.
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start8 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet Syndrome, Intestinal TypeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849908
- Sponsor's protocol ID
- Baricitinib-IBS-PUMCH
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Refractory Intestinal Behçet's Syndrome Patients
- ClinicalTrials.gov ID
- NCT06849908
- Acronym / sponsor ID
- Baricitinib-IBS-PUMCH
- Conditions
- Behcet Syndrome, Intestinal Type
- Keywords
- Baricitinib, Adalimumab, Intestinal Behçet's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib for IBS | Experimental | Drug: Baricitinib |
| Adalimumab for IBS | Experimental | Drug: Adalimumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: Olumiant®Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with Baricitinib 4 mg/day for 6 months. | Drug | Baricitinib for IBS |
| AdalimumabAlso: Humira®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. | Drug | Adalimumab for IBS |
Primary outcome
Proportion of patients with marked improvement (MI) at week 24 of follow-up
Time frame: Baseline to week 24
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).
9 secondary outcomes
Proportion of patients with CR (complete response) at week 24 of follow-up
Time frame: 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
Time frame: Baseline to week 24
Changes in C-reactive protein (CRP) compared to baseline
Time frame: Baseline to week 24
Changes in erythrocyte sedimentation rate (ESR) compared to baseline
Time frame: Baseline to week 24
Changes in DAIBD scores compared to baseline
Time frame: Baseline to week 24
Changes in BDCAF scores compared to baseline
Time frame: Baseline to week 24
Changes in SF-36 of life questionnaires compared to baseline
Time frame: Baseline to week 24
Changes in IBDQ quality of life questionnaires compared to baseline
Time frame: Baseline to week 24
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Behcet Syndrome, Intestinal Type
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjie Zheng, M.D. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib and Adalimumab in people with Behcet Syndrome, Intestinal Type, run by Peking Union Medical College Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinjing Liu, M.D. (86-10-69151188, pumch_followup@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with marked improvement (MI) at week 24 of follow-up (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.