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

InnoCare Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: ICP-022; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT04305197

ICP-CL-00109

Details and patient eligibility

About

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)

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 4 patient groups, including a placebo group

Lower Dose

Experimental group

Treatment:

Drug: ICP-022

Drug: ICP-022

Drug: ICP-022

Medium Dose

Experimental group

Treatment:

Drug: ICP-022

Drug: ICP-022

Drug: ICP-022

Higher Dose

Experimental group

Treatment:

Drug: ICP-022

Drug: ICP-022

Drug: ICP-022

Placebo

Placebo Comparator group

Treatment:

Drug: Placebos