RECRUITING

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 Dapirolizumab pegol SLE DZP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Quick Facts

Study Start:2024-11-21

Study Completion:2027-03-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06617325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Study participant must be ≥16 years of age, 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: 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 corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR * Treatment with corticosteroids 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)	* 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 an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder * 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 defined 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

Inclusion Criteria

Exclusion Criteria

* Study participant must be ≥16 years of age, 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:
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 corticosteroids and/or immunosuppressants or as stand-alone treatment if justified OR
* Treatment with corticosteroids 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)

* 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 an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
* 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 defined 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

Contacts and Locations

Study Contact

UCB Cares

CONTACT

1-844-599-2273

ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273

Principal Investigator

UCB Cares

STUDY_DIRECTOR

001 844 599 2273 (UCB)

Study Locations (Sites)

Sl0044 50681

Miami, Florida, 33172

United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273 (UCB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21

Study Completion Date2027-03-02

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2027-03-02

Terms related to this study

Keywords Provided by Researchers

Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus