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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07663526
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 23, 2026
Start date
Aug 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tabellvi® Adalimumab Injection
    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.

Primary Outcome Measure

Serious Adverse Event (SAE) [ Time Frame: Baseline up to 54 weeks ]

Central Contacts

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