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-ES
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study<br>2. Incidence of serious treatment-emergent adverse events during the study<br>3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation;Timepoint(s) of evaluation of this end point: 1-3: From Baseline (Day 1) until Safety Follow-Up (up to Week 110);Main Objective: Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment.;Secondary Objective: Evaluate the ability of dapirolizumab pegol (DZP) treatment:<br>- to prevent relevant disease flares<br>- to achieve and maintain the treat-to-target goal: low lupus disease activity state (LLDAS)<br>- to maintain long-term clinical response

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24<br>2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52<br>3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104<br>4. Achievement of LLDAS at >/= 50% of all visits<br>5. Achievement of BICLA response at Week 24<br>6. Achievement of BICLA response at Week 52<br>7. Achievement of BICLA response at Week 104;Timepoint(s) of evaluation of this end point: 1, 5: Week 24<br>2, 6: Week 52<br>3, 7: Week 104<br>4: From Baseline (Day 1) until End of Treatment (Week 104)