New study tests Anti-Inflammatory drug for Crohn's in china
NCT ID NCT07663526
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test the drug Tabellvi (adalimumab) in 50 Chinese adults with moderate to severe Crohn's disease. The goal is to see how safe and effective it is in real-world settings, focusing on side effects and whether patients achieve remission after 26 weeks. Participants must have failed other treatments like steroids or immunosuppressants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adalimumab (Tabellvi), a drug that blocks inflammation
- What this could lead to
- If successful, this could confirm that adalimumab works well and safely for Chinese patients with Crohn's disease in everyday medical practice.
- What could go wrong
- This is a small, single-arm study with no comparison group, so results may not be definitive. Side effects like infections or allergic reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The subject must sign the informed consent form. * Aged 18 to 70 years inclusive, no gender restriction. * Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response, intolerance or contraindication to adequate glucocorticoid and/or immunosuppressant therapy. * Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment. * Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator. Exclusion Criteria: * Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician. * Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period. * Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection. * Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis). * Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose. * Subjects with active tuberculosis infection; or latent tuberculosis infection without adequate treatment; subjects infected with human immunodeficiency virus (HIV); subjects positive for hepatitis C virus antibody (HCV Ab) indicating previous or current infection; subjects positive for hepatitis B surface antigen (HBsAg), or positive for total hepatitis B core antibody (total Hepatitis B core Ab) with positive hepatitis B virus (HBV)-DNA polymerase chain reaction test result. * Subjects with syphilis infection requiring treatment. * Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study. * Subjects with current evidence of dysplasia or a history of malignant tumors (including lymphoma and leukemia), except cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized cervical carcinoma in situ. * Subjects with a history of demyelinating diseases (including myelitis), or neurological symptoms suggestive of demyelinating diseases. * Subjects who have undergone intestinal resection within the past 6 months, or plan to undergo intestinal resection at any time in the future. * Subjects receiving total parenteral nutrition (TPN), or planning to receive TPN at any time during the study period. * Subjects with an ostomy or an ileal pouch-anal anastomosis (IPAA) pouch. * Subjects with internal or external fistulas, except perianal fistulas without abscess. * Subjects with known symptomatic obstructive intestinal strictures. * Subjects diagnosed with ulcerative colitis or indeterminate colitis. * Subjects with any of the following abnormal laboratory or other examination results during the screening period: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 times the upper limit of the reference range; white blood cell count \< 3.0×10⁹/L; electrocardiogram (ECG) with clinically significant abnormalities; total bilirubin ≥3 mg/dL (isolated elevated indirect bilirubin caused by Gilbert's syndrome excluded); serum creatinine \>1.6 mg/dL. * Subjects with other clinically significant abnormal laboratory test results (other than those listed above) identified by the investigator during screening. * Subjects who have received other tumor necrosis factor-alpha (TNF-α) inhibitor therapy within 12 weeks before receiving the first dose of Tabellvi® Adalimumab Injection. * Subjects currently participating in another clinical study. * Subjects deemed unsuitable for participation in this trial by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuyang People's Hospital
Fuyang, Anhui, 236000, China
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Huai'an First People's Hospital
Huaian, Jiangsu, 223001, China
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Meihekou Central Hospital
Meihekou, Jilin, 135022, China
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Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200001, China
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The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
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Yancheng No.1 People's Hospital
Yancheng, Jiangsu, 224500, China
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Zhoukou Central Hospital
Zhoukou, Henan, 466000, China
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- AI reads scans to forecast Crohn's complications