A Clinical Trial on the Efficacy and Safety of TQH3906 in the Treatment of Systemic Lupus Erythematosus

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• TQH3906 capsule — DRUG
  The TQH3906 capsule is a Tyrosine Kinase 2 (TYK2) inhibitor.
• TQH3906 placebo — DRUG
  Placebo without drug.

Study Details

To assess the efficacy and safety of TQH3906 in treating systemic lupus erythematosus.

Key Dates

First listed

Apr 3, 2026

Start date

Jun 22, 2026

Status verified

Feb 2026

Primary completion

Nov 30, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

198 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 16 mg TQH3906 capsule
  16 mg TQH3906 capsule, oral administration, once daily, for a duration of 48 weeks.
• Experimental: 24 mg TQH3906 capsules
  24 mg TQH3906 capsule, oral administration, once daily, for a duration of 48 weeks.
• Placebo Comparator: TQH3906 placebo
  Placebo, oral administration, once daily, for a duration of 48 weeks.

Primary Outcome Measure

The percentage of participants who achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) [ Time Frame: Baseline to week 32. ]

Central Contacts

• Zhanguo Li, Doctor
  13910713924
  [email protected]

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