A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
UCB Biopharma SRL
Study ID
NCT04976322
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapirolizumab pegol — DRUG
    Subjects will receive dapirolizumab pegol at prespecified time-points.

Study Details

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Key Dates

Start date
Jul 27, 2021
Status verified
May 2026
Primary completion
Aug 7, 2030
Completion
Aug 7, 2030

Study Design

Enrollment
760 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapirolizumab pegol
    Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110) ]

Locations (29)

FacilityCityStateZIPSite coordinators
Sl0046 50140BirminghamAlabama35294-
Sl0046 50058AvondaleArizona85392-
Sl0046 50328TucsonArizona85704-
Sl0046 50383Beverly HillsCalifornia90210-
Sl0046 50275La PalmaCalifornia90623-1730-
Sl0046 50316San LeandroCalifornia94578-
Sl0046 50339DenverColorado80230-
Sl0046 50239BrandonFlorida33511-
Sl0046 50362GainesvilleFlorida32610-
Sl0046 50681MiamiFlorida33172-
Sl0046 50059Ormond BeachFlorida32174-
Sl0046 50324PlantationFlorida33324-
Sl0046 50329TampaFlorida33606-
Sl0046 50698TampaFlorida33614-
Sl0046 50368AtlantaGeorgia30303-
Sl0046 50240Idaho FallsIdaho83404-
Sl0046 50474HopkinsvilleKentucky42240-1746-
Sl0046 50285Lake CharlesLouisiana70605-
Sl0046 50015HagerstownMaryland21740-
Sl0046 50219DetroitMichigan48201-
Sl0046 50273Las VegasNevada89128-
Sl0046 50366CantonNew York13617-
Sl0046 50264ManhassetNew York11030-
Sl0046 50334New YorkNew York10032-
Sl0046 50238CharlotteNorth Carolina28211-
Sl0046 50147HersheyPennsylvania17033-
Sl0046 50001JacksonTennessee38305-
Sl0046 50418ColleyvilleTexas76034-
Sl0046 50050BeckleyWest Virginia25801-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Sl0046 50140· Birmingham, ALSl0046 50058· Avondale, AZSl0046 50328· Tucson, AZSl0046 50383· Beverly Hills, CASl0046 50275· La Palma, CASl0046 50316· San Leandro, CA

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