A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Criteria

Inclusion Criteria:

1. Male or female subjects aged 18 to 75

2. diagnosis of with SLE at least 6 months at screening visit

3. SLEDAE-2K≥5

4. Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.

5. At least one SLE activity manifestation (as assessed by SLEDAE-2K)

Exclusion Criteria:

1. Failure to comply with the requirements of the programme

2. A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period

3. Previously treated with a BTK inhibitor

4. Neuropsychiatric lupus (NPSLE)

5. Has other autoimmune diseases other than SLE

Note: Other protocol defined Inclusion/Exclusion criteria may apply.