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Clinical Trials List

Protocol NumberSL0043
NCT Number(ClinicalTrials.gov Identfier)NCT04294667

2019-09-01 - 2024-05-14

Phase III

Not yet recruiting8

ICD-10M32.0

Drug-induced systemic lupus erythematosus

ICD-10M32.10

Systemic lupus erythematosus, organ or system involvement unspecified

ICD-10M32.11

Endocarditis in systemic lupus erythematosus

ICD-10M32.12

Pericarditis in systemic lupus erythematosus

ICD-10M32.13

Lung involvement in systemic lupus erythematosus

ICD-10M32.14

Glomerular disease in systemic lupus erythematosus

ICD-10M32.15

Tubulo-interstitial nephropathy in systemic lupus erythematosus

ICD-10M32.19

Other organ or system involvement in systemic lupus erythematosus

ICD-10M32.8

Other forms of systemic lupus erythematosus

ICD-10M32.9

Systemic lupus erythematosus, unspecified

ICD-9710.0

Systemic lupus erythematosus

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    UCB Biopharma SRL

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Wei-Sheng Chen Division of General Internal Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳堃宏 Division of General Internal Medicine
Cathay General Hospital

Co-Principal Investigator

  • 全以祖 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shue-Fen Lo Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 田雅之 Division of General Internal Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳相成 風濕免疫科
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 魏正宗 風濕免疫科
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yi-Hsing Chen Division of General Internal Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator SONG-CHOU HSIEH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Moderately to Severely Active Systemic Lupus Erythematosus

Objectives

Primary  To evaluate the ability of DZP as an addon treatment to SOC medication to achieve clinically relevant long term improvement of moderate to severe disease activity Key Secondary  To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve fast, clinically relevant improvement of moderate to severe disease activity  To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve long term control of disease activity  To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time  To evaluate the ability of DZP as an add-on treatment to SOC medication to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice

Test Drug

dapirolizumab pegol

Active Ingredient

dapirolizumab pegol

Dosage Form

Lyophilized Powder for Injection

Dosage

100

Endpoints

Primary Outcome Measures :
Achievement of BICLA response at Week 48 [ Time Frame: Week 48 ]
A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled:

British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10mm increase on a 100mm visual analog scale
Escape treatment intervention as indicated by Investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward.

Inclution Criteria

Inclusion Criteria:

Study participant must be ≥16 years of age
Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as:

Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry by a qualified physician
Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
With serological evidence for SLE at Screening as demonstrated by at least 1 of the following:
i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 < lower limit of normal (LLN) OR complement C4
Anti-Smith (anti-Sm) antibodies (central laboratory)
Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
Historic evidence for anti-dsDNA antibodies 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 Screening Visit AND
SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following SOC medication 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 anti-malarial treatment is not possible

Exclusion Criteria

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

Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, 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 evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
Study participant had a reactivated latent or opportunistic 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 clinically significant active or latent infection
Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
Study participant takes any protocol defined prohibited concomitant medication
Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (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 <30mL/min/1.73m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    450 participants

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