A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DZP — DRUG
  Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
• Placebo — OTHER
  Study participants will receive placebo at prespecified time-points.

Study Details

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Key Dates

Start date

Nov 21, 2024

Status verified

May 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dapirolizumab pegol
  Study participants will receive dapriolizumab pegol throughout the Treatment Period.
• Placebo Comparator: Placebo
  Study participants will receive placebo throughout the Treatment Period.

Primary Outcome Measure

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48 [ Time Frame: Week 48 ]

Central Contacts

• UCB Cares
  1-844-599-2273
  [email protected]
• UCB Cares
  001 844 599 2273

Locations (61)

Find similar trials in Avondale, AZ

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