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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Willingness to participate in the study and ability to sign an informed consent form.

Willingness and ability to complete all research-related procedures and site visits.

Screen for patients with a confirmed diagnosis of SLE dating back to at least 24 weeks prior to the visit.

Diagnosed with systemic lupus erythematosus according to the 2019 classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).

Disqualifiers

drug-induced SLE;

Trial participants with other autoimmune diseases (e.g. multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) were excluded. Test participants with secondary dry syndrome could not be excluded;

Excluded trial participants with overlapping syndromes of SLE, such as systemic sclerosis and mixed associative weaving disease;

In the case of a combination of antiphospholipid syndrome secondary to systemic lupus erythematosus, prior severe blood clots / obstetric complications need to be ruled out; Prophylaxis with low-dose aspirin (50-100 mg / d) in the absence of thrombotic events or obstetric comorbidities and with high-risk antiphospholipid antibody (aPL) characteristics may be included;

Trial design

Treatments tested in this trial

  • TQH3906 capsule
  • TQH3906 placebo

Treatment groups

198 Participants
are divided into 3 treatment groups