A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapirolizumab pegol.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, Bulgaria, Canada +19
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
Interventions
- Drug Dapirolizumab pegol
Subjects will receive dapirolizumab pegol at prespecified time-points.
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) during the study [Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)]
- Incidence of serious treatment-emergent adverse events during the study [Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)]
- 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)]
Secondary outcome measures (7)
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24 [Time frame: Week 24]
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52 [Time frame: Week 52]
- Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104 [Time frame: Week 104]
- Achievement of LLDAS at ≥50% of all visits [Time frame: From Baseline (Day 1) until End of Treatment (Week 104)]
- Achievement of BICLA response at Week 24 [Time frame: Week 24]
- Achievement of BICLA response at Week 52 [Time frame: Week 52]
- Achievement of BICLA response at Week 104 [Time frame: Week 104]
Eligibility 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 32 centers
- Sl0046 50140 — Birmingham
- Sl0046 50058 — Avondale
- Sl0046 50662 — Glendale
- Sl0046 50052 — Phoenix
- Sl0046 50328 — Tucson
- Sl0046 50383 — Beverly Hills
- Sl0046 50275 — La Palma
- Sl0046 50316 — San Leandro
- … and 24 more centers
Poland · 11 centers
Center list to be confirmed — check the primary protocol.
China · 10 centers
- Sl0046 20128 — Beijing
- Sl0046 20291 — Changchun
- Sl0046 20019 — Guangzhou
- Sl0046 20290 — Guilin
- Sl0046 20020 — Shanghai
- Sl0046 20204 — Suzhou
- Sl0046 20136 — Tianjin
- Sl0046 20025 — Wenzhou
- … and 2 more centers
Colombia · 7 centers
- Sl0046 60013 — Barranquilla
- Sl0046 60019 — Barranquilla
- Sl0046 60006 — Bogotá
- Sl0046 60027 — Bogotá
- Sl0046 60016 — Bucaramanga
- Sl0046 60007 — Chía
- Sl0046 60031 — Montería
Argentina · 6 centers
- Sl0046 60002 — Buenos Aires
- Sl0046 60029 — Mendoza
- Sl0046 60003 — Quilmes
- Sl0046 60022 — Quilmes
- Sl0046 60011 — San Juan
- Sl0046 60014 — San Miguel de Tucumán
Germany · 6 centers
- Sl0046 40386 — Cologne
- Sl0046 40072 — Freiburg im Breisgau
- Sl0046 40027 — Herne
- Sl0046 40078 — Leipzig
- Sl0046 40402 — Tübingen
- Sl0046 40715 — Vogelsang-gommern
Mexico · 6 centers
Center list to be confirmed — check the primary protocol.
Japan · 5 centers
Center list to be confirmed — check the primary protocol.
Canada · 4 centers
- Sl0046 50374 — Calgary
- Sl0046 50337 — Edmonton AB
- Sl0046 50259 — Rimouski
- Sl0046 50045 — Toronto
Greece · 4 centers
- Sl0046 40378 — Athens
- Sl0046 40501 — Athens
- Sl0046 40377 — Crete
- Sl0046 40507 — Larissa
Hungary · 4 centers
- Sl0046 40412 — Budapest
- Sl0046 40411 — Debrecen
- Sl0046 40031 — Szeged
- Sl0046 40499 — Székesfehérvár
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Bulgaria · 2 centers
- Sl0046 40189 — Plovdiv
- Sl0046 40380 — Sofia
Chile · 2 centers
- Sl0046 60015 — Santiago
- Sl0046 60018 — Santiago
Italy · 2 centers
- Sl0046 40084 — Catania
- … and 1 more center
Peru · 2 centers
Center list to be confirmed — check the primary protocol.
Philippines · 2 centers
Center list to be confirmed — check the primary protocol.
Serbia · 2 centers
Center list to be confirmed — check the primary protocol.
South Korea · 2 centers
Center list to be confirmed — check the primary protocol.
Belgium · 1 center
- Sl0046 40123 — Brussels
Czechia · 1 center
- Sl0046 40066 — Prague
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Romania · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04976322 · SL0046 · 2019-003409-83 · U1111-1293-7098 · 2023-506368-14