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

UCB

Status and phase: Invitation-only; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Dapirolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04976322

U1111-1293-7098 (Other Identifier)

SL0046

2019-003409-83 (EudraCT Number)

2023-506368-14 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 760 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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760 participants in 1 patient group

Dapirolizumab pegol

Experimental group

Description:

Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Treatment:

Drug: Dapirolizumab pegol