Crohn's DiseasePhase 4NCT07663526
Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®
A Phase 4 study testing TyboWe® Adalimumab Injection in people with Crohn's Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial summary
This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- TyboWe® Adalimumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesChina
- Study dates
- 23 Sep 2026to Mar 2029
- Phase
- Phase 4
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Fuyang People's Hospital
Fuyang, Anhui, 236000
Baogui Wang, Master, 13805582057, wangbaogui99@163.com
- Not yet recruiting
Huai'an First People's Hospital
Huaian, Jiangsu, 223001
Honggang Wang, Doctor, 18851268720, jgzwhg@nymu.edu.cn
- Not yet recruiting
Meihekou Central Hospital
Meihekou, Jilin, 135022
Zhongwei Pan, Master, 13179198955, 13179198955@163.com
- Recruiting
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200001
Jun Shen, Doctor, 13651829887, shenjun@vip.163.com
- Not yet recruiting
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, 224500
Hongmei Yang, Bachelor, 13805102106, 196206yhm@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Gaofeng Lu, Doctor, 15637102290, lugaofeng78@163.com
- Not yet recruiting
Zhoukou Central Hospital
Zhoukou, Henan, 466000
Junying Liu, Doctor, 18539768877, liujunying781025@163.com
About this study
Official title: A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting
This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score < 150) at Week 26.
- Conditions
- Crohn's Disease
- Being tested
- TyboWe® Adalimumab Injection
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TyboWe® Adalimumab InjectionDrug
Adalimumab is a human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking TNF-α, a core inflammatory factor in psoriasis.
| Study group | Role | What they receive |
|---|---|---|
| Tabellvi® Adalimumab Injection | Experimental | The induction dosage is 160 mg at Week 0, followed by 80 mg at Week 2. After induction therapy, the recommended maintenance dosage is 40 mg administered subcutaneously once every 2 weeks.
Administer subcutaneously once every two weeks. For induction therapy, the dosage is 160 mg at Week 0, followed by 80 mg at Week 2. After induction therapy, the recommended maintenance dose is 40 mg administered subcutaneously once every two weeks. Receives: Drug: TyboWe® Adalimumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Event (SAE)
Incidence rate of serious adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Measured: Baseline up to 54 weeks
Adverse Event (AE)
Incidence rate of adverse events，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Measured: Baseline up to 54 weeks
Adverse Drug Reaction (ADR)
Incidence rate of adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Measured: Baseline up to 54 weeks
Serious Adverse Drug Reaction
Incidence rate of serious adverse drug reaction，the severity will be graded according to the NCI CTCAE Version 6.0 grading scale.
Measured: Baseline up to 54 weeks
Clinical remission (CDAI < 150)
The proportion of subjects achieving clinical remission (CDAI score<150) at Week 26
Measured: At Week 26 post-dose
Secondary outcomes (5)
Clinical remission (CDAI < 150)
The proportion of subjects achieving clinical remission (CDAI < 150) at Weeks 4, 12, and 52 post-dose.
Measured: At Weeks 4, 12, and 52 post-dose
Clinical response (reduction in CDAI ≥70 points from baseline)
The proportion of subjects achieving clinical response (CDAI reduction ≥70 points from baseline) at Weeks 4, 12, 26, and 52 post-dose.
Measured: At Weeks 4, 12, 26 and 52 post-dose
Endoscopic remission
The proportion of subjects achieving endoscopic remission at Week 26 post-dose
Measured: At Week 26 post-dose
C-reactive protein (CRP)
Changes in C-reactive protein (CRP) from baseline at Weeks 12, 26, and 52 post-dose.
Measured: At Weeks 12, 26, and 52 post-dose
Fecal calprotectin (FC)
Changes in fecal calprotectin (FC) from baseline at Weeks 12, 26, and 52 after administration.
Measured: At Weeks 12, 26, and 52 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start23 Sep 2026
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663526
- Sponsor's protocol ID
- ADM-IV-02
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No