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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 May 2025 |
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Main ID: |
NCT04976322 |
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Date of registration:
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14/07/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
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Scientific title:
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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 |
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Date of first enrolment:
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July 27, 2021 |
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Target sample size:
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760 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04976322 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Belgium
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Bulgaria
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Canada
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Chile
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Colombia
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Czechia
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Germany
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Greece
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Hungary
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Italy
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Korea, Republic of
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Mexico
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Peru
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Philippines
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Poland
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Romania
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Serbia
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Spain
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Taiwan
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United States
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Contacts
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Name:
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UCB Cares |
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Address:
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Telephone:
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Email:
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Affiliation:
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001 844 599 2273 (UCB) |
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Key inclusion & exclusion criteria
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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 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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Dapirolizumab pegol
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Primary Outcome(s)
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Incidence of serious treatment-emergent adverse events during the study
[Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)]
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Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
[Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)]
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Incidence of treatment-emergent adverse events (TEAEs) during the study
[Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)]
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Secondary Outcome(s)
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Achievement of LLDAS at =50% of all visits
[Time Frame: From Baseline (Day 1) until End of Treatment (Week 104)]
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Achievement of BICLA response at Week 52
[Time Frame: Week 52]
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Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
[Time Frame: Week 24]
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Achievement of BICLA response at Week 104
[Time Frame: Week 104]
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Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
[Time Frame: Week 52]
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Achievement of BICLA response at Week 24
[Time Frame: Week 24]
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Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
[Time Frame: Week 104]
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Secondary ID(s)
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2019-003409-83
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SL0046
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2023-506368-14
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U1111-1293-7098
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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