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Looking for participantsPhase3

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

Sponsor: UCB Biopharma SRL

NCT ID: NCT06617325

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
DZP (drug), Placebo (other)
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
DZP — drug: Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points. · Placebo — other: Study participants will receive placebo at prespecified time-points.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
450
Started
2024-11-21
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic lupus erythematosus
  • • Phase3 - 450 participants
  • • 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

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with systemic lupus erythematosus

Where?

  • • Bath - Sl0044 40847
  • • Belfast - Sl0044 40858
  • • Leeds - Sl0044 40281
  • • London - Sl0044 40113
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Systemic Lupus Erythematosus

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at...
  • ✓Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
  • ✓Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies...
  • ✓Historical evidence for anti-dsDNA antibodies
  • ✓Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:

Who cannot take part

  • ✗Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
  • ✗Study participant has clinically significant active or latent infection
  • ✗Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study...
  • ✗Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol
  • ✗Study participant has previously been randomly assigned within this study or has previously been assigned to treatment with...
See the full criteria
Inclusion Criteria: * Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF) * Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as: a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \<lower limit of normal (LLN) OR complement C4 \<LLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies: 1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history) 2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory) 3. Historical evidence for anti-dsDNA antibodies 4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as: * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose: * Antimalarial treatment in combination with glucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR * Treatment with glucocorticoids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability) Exclusion Criteria: * Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric 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 * Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy * Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \[eg, curettage, electrodesiccation\] not later than 4 weeks prior to the Screening Visit \[V1\]), basal cell carcinoma, or dermatological squamous cell carcinoma * Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE * Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study * Study participant has clinically significant active or latent infection * Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection * Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion * Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol * Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP * Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP * Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2, or serum creatinine \>2.5 mg/dL, or participant has proteinuria \>3g/day, or protein:creatinine ratio \>340 mg/mmol at the Screening Visit

Where Is This Study? (7 UK sites)

Sl0044 40847

Bath, United Kingdom

Recruiting

Sl0044 40858

Belfast, United Kingdom

Recruiting

Sl0044 40281

Leeds, United Kingdom

Recruiting

Sl0044 40113

London, United Kingdom

Recruiting

Sl0044 40864

Newcastle upon Tyne, United Kingdom

Recruiting

Sl0044 40701

Sheffield, United Kingdom

Recruiting

Sl0044 40725

West Bromwich, United Kingdom

Recruiting

How to Get in Touch

UCB Cares

Sponsor contact

CONTACT

1-844-599-2273 ucbcares@ucb.com

UCB Cares

Sponsor contact

CONTACT

001 844 599 2273
Data sourced from ClinicalTrials.gov · Last verified: 2026-09