Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®

NCT07663526 | Not Yet Recruiting Phase 4

• 1 other identifier: ADM-IV-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  Baseline up to 54 weeks

• Clinical remission (CDAI < 150)

  The proportion of subjects achieving clinical remission (CDAI score\<150) at Week 26

  At Week 26 post-dose

Secondary Outcomes (5)

• Clinical remission (CDAI < 150)

  At Weeks 4, 12, and 52 post-dose

• Clinical response (reduction in CDAI ≥70 points from baseline)

  At Weeks 4, 12, 26 and 52 post-dose

• Endoscopic remission

  At Week 26 post-dose

• C-reactive protein (CRP)

  At Weeks 12, 26, and 52 post-dose

• Fecal calprotectin (FC)

  At Weeks 12, 26, and 52 post-dose

Study Arms (1)

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.

Drug: TyboWe® Adalimumab Injection

Interventions

TyboWe® Adalimumab Injection DRUG

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.

Tabellvi® Adalimumab Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (7)

Fuyang People's Hospital

Fuyang, Anhui, 236000, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

Zhoukou Central Hospital

Zhoukou, Henan, 466000, China

Location

Huai'an First People's Hospital

Huaian, Jiangsu, 223001, China

Location

Yancheng No.1 People's Hospital

Yancheng, Jiangsu, 224500, China

Location

Meihekou Central Hospital

Meihekou, Jilin, 135022, China

Location

Shanghai Jiao Tong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Jun Shen, Doctor

CONTACT

13651829887; shenjun@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-02

Locations

CN (7)