Recruiting NCT06617325

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

Phase III Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: DZP, Placebo.
Who it may be relevant to: Registry conditions: Systemic Lupus Erythematosus. Basic parameters: from 16 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Belgium, Canada, Chile +17
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

Drug DZP
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Other Placebo
Study participants will receive placebo at prespecified time-points.

Primary outcome measures

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48 [Time frame: Week 48]

Secondary outcome measures (12)

Achievement of SRI 4 response at Week 48 [Time frame: Week 48]
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48 [Time frame: Week 48]
Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48 [Time frame: Week 40 to Week 48]
Change from Baseline to Week 48 in the FATIGUE-PRO Total score [Time frame: From Baseline to Week 48]
Percentage of participants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline to ≤7.5mg/day at Week 36 and maintained through Week 48 [Time frame: From Baseline to Week 48]
Achievement of BILAG 2004 improvement without worsening at Week 48 [Time frame: Week 48]
Change from Baseline in PGA at Week 48 [Time frame: From Baseline to Week 48]
Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48 [Time frame: During Treatment Period up to Week 48]
Change from Baseline in SLEDAI-2K at Week 48 [Time frame: From Baseline to Week 48]
Change from Baseline in FACIT-Fatigue score at Week 48 [Time frame: From Baseline to Week 48]
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [Time frame: From Baseline until Safety Follow-Up (up to Week 54)]
Percentage of participants with serious treatment-emergent adverse events during the study [Time frame: From Baseline until Safety Follow-Up (up to Week 54)]

Eligibility 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:

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 (central laboratory)
Historical evidence for anti-dsDNA antibodies
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 61 centers

Sl0044 50058 — Avondale
Sl0044 50550 — Chandler
Sl0044 50713 — Gilbert
Sl0044 50662 — Glendale
Sl0044 50052 — Phoenix
Sl0044 50677 — Scottsdale
Sl0044 50670 — Searcy
Sl0044 50737 — Beverly Hills
… and 53 more centers

China · 36 centers

Sl0044 20293 — Baotou
Sl0044 20128 — Beijing
Sl0044 20157 — Beijing
Sl0044 20173 — Beijing
Sl0044 20201 — Bengbu
Sl0044 20291 — Changchun
Sl0044 20342 — Changchun
… and 29 more centers

Japan · 29 centers