A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus

Phase 1

• Conditions: Systemic lupus erythematosus; MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-003409-83-AT
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-28
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: A
• 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 708
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

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