A study to learn if dapirolizumab pegol is safe and works long-term in people with systemic lupus erythematosus

Phase 1

Recruiting

• Conditions: Systemic lupus erythematosus (SLE); MedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-506368-14-00
• Lead Sponsor: CB Biopharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment - The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study

Exclusion Criteria

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified