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Enrolling by invitationPhase 3

Long-term safety of dapirolizumab pegol in people with lupus

Tests dapirolizumab pegol's long-term safety in people with systemic lupus erythematosus.

Key facts

Who runs it
UCB Biopharma SRL
Where
Barranquilla, Bogotá, Bucaramanga, Chía, and Montería, ColombiaSee the 7 sitesAlso in 26 other countries, 177 sites
Registry title
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
Status
Enrolling by invitation
Phase
Phase 3
People taking part
760 people, planned
Started
27 Jul 2021
Expected to end
7 Aug 2030
Type of study
Interventional
Treatments tested
  • Dapirolizumab pegol
Record updated
15 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with systemic lupus erythematosus (SLE) who finished an earlier dapirolizumab pegol study and could benefit from long-term treatment with it.

Age
16 years or older
Sex
All sexes can join.
Earlier treatment
Must have finished one of the parent studies within 4 weeks before joining this study.

Main reasons for not taking part

  • A medical or mental health condition that, in the investigator's opinion, could jeopardize or compromise the ability to take part, including conditions due to neuropsychiatric SLE
  • A life-threatening condition at the start of the study
  • An ongoing cancer (malignancy) at the start of the study

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Colombia

Also in 26 other countries, 177 sites

  • Sl0046 60013Barranquilla, ColombiaNo longer taking part
  • Sl0046 60019Barranquilla, ColombiaNo longer taking part
  • Sl0046 60006Bogotá, ColombiaNo longer taking part
  • Sl0046 60027Bogotá, ColombiaNo longer taking part
  • Sl0046 60016Bucaramanga, ColombiaNo longer taking part
  • Sl0046 60007Chía, ColombiaNo longer taking part
  • Sl0046 60031Montería, ColombiaNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • Dapirolizumab pegolTreatment being tested

    Subjects will receive dapriolizumab pegol throughout the Treatment Period.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Long-term safety of dapirolizumab pegol in people with lupusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 October 2026