A Research Study to Evaluate the Effects of a New Oral Medicine CalledCenerimod in Adults With Systemic Lupus Erythematosus (OPUS-1)

Phase 3

Not yet recruiting

• Conditions: Systemic lupus erythematosus, unspecified,

• Registration Number: CTRI/2025/06/089546
• Lead Sponsor: Idorsia Phamaceuticals Ltd

Brief Summary

The goal of this clinicaltrial is to see how well cenerimod reduces symptoms of Systemic LupusErythematosus in adult patients with moderate to severe symptoms.

The main questionsit aims to answer are:

• How well cenerimod workson top of the treatment already being administered.

• How safe cenerimod is foradult patients with Systemic Lupus Erythematosus.

Researchers will compare onedose of cenerimod and a placebo to see how well cenerimod works whenit is added to the treatment already being administered.

In this research study approximately 210 participantswill receive cenerimod and approximately 210 participants will receive placebofor 12 months.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-25
• Study Start: 2025-07-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• 1.Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism or American College of Rheumatology Criteria.
• 2.A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score greater than or equal to 6 and clinical mSLEDAI-2K score greater than or equal to 4.
• 3.British Isles Lupus Assessment Group-2004 (BILAG) Grade B in at least 2 organ systems or a BILAG Grade A in at least 1 organ system.

Exclusion Criteria

• 1.Pregnant, planning to be become pregnant up to Final Study Visit or lactating woman 2.
• Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE.
• A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline. Response on SRI-4 is defined as	At Month 12 compared to Day 1
• Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index 2000 score (mSLEDAI-2K [SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K]), and	At Month 12 compared to Day 1
• No new British Isles Lupus Assessment Group 2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and	At Month 12 compared to Day 1
• No worsening from baseline in subjects’ lupus disease activity, where worsening is defined as an increase greater than or equal to 0.30 points on a 3 point Physician’s Global Assessment visual analog scale (PGA VAS), and	At Month 12 compared to Day 1
• No violation of specified medication rules detailed in the core protocol.	At Month 12 compared to Day 1

Secondary Outcome Measures

Name	Time	Method
1. Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline.	At Month 12 compared to Day 1

Trial Locations

Locations (4)

Assure Care Plus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

ChanRe Rheumatology and Immunology Centre and Research; 🇮🇳 Bangalore, KARNATAKA, India

Rajiv Gandhi Government General Hospital; 🇮🇳 Chennai, TAMIL NADU, India

St. Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Assure Care Plus Hospital

🇮🇳Nashik, MAHARASHTRA, India

Dr Praveen Pratap Jadhav

Principal investigator

8358933951

drpraveenjadhav@rediffmail.com