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

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003409-83-PL

Enrollment

760

Registered

2021-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Dapirolizumab pegol Product Code: CDP7657 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Dapirolizumab pegol Current Sponsor code: DZP Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment. ;Secondary Objective: Evaluate the ability of dapirolizumab pegol (DZP) treatment: - to prevent relevant disease flares - to achieve and maintain the treat-to-target goal: low lupus disease activity state (LLDAS) - to maintain long-term clinical response ;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 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)	—

Measure

Time frame

Main Objective: Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment. ;Secondary Objective: Evaluate the ability of dapirolizumab pegol (DZP) treatment: - to prevent relevant disease flares - to achieve and maintain the treat-to-target goal: low lupus disease activity state (LLDAS) - to maintain long-term clinical response ;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 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)

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Secondary

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

Measure

Time frame

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

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Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Portugal, Romania, Serbia, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactClin Trial Reg & Results Disclosure

UCB BIOSCIENCES GmbH

clinicaltrials@ucb.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026