A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

Phase 3Enrolling By InvitationNCT04976322

UCB Biopharma SRL760 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

760

Conditions

Systemic Lupus Erythematosus

Interventions

Dapirolizumab pegolDRUG

Subjects will receive dapirolizumab pegol at prespecified time-points.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 or ongoing malignancies at the start of the study

Locations (115)

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs) during the study

Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

Incidence of serious treatment-emergent adverse events during the study

A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above

Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation

Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, and leading to permanent drug discontinuation whether or not these events are related to study treatment.

Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

Secondary Outcomes

Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24

BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).

Data from ClinicalTrials.gov

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Sl0046 50140

Birmingham, Alabama, United States

Sl0046 50058

Avondale, Arizona, United States

Sl0046 50328

Tucson, Arizona, United States

Sl0046 50383

Beverly Hills, California, United States

Sl0046 50275

La Palma, California, United States

Sl0046 50316

San Leandro, California, United States

Sl0046 50339

Denver, Colorado, United States

Sl0046 50239

Brandon, Florida, United States

Sl0046 50362

Gainesville, Florida, United States

Sl0046 50681

Miami, Florida, United States

...and 105 more locations

Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52

Time frame: Week 52

Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104

Time frame: Week 104

Achievement of LLDAS at ≥50% of all visits

Low lupus disease activity state (LLDAS) is defined as: * No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) * No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit * PGA ≤33 mm * Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day * Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol

Time frame: From Baseline (Day 1) until End of Treatment (Week 104)

Achievement of BICLA response at Week 24

A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled: 1. 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 2. 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 3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.

Time frame: Week 24

Achievement of BICLA response at Week 52

A study participant is considered to be a BICLA responder if all of the following is fulfilled: 1. 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 2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and 3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale The parent studies Baseline will be used as reference point.

Time frame: Week 52

Achievement of BICLA response at Week 104

Time frame: Week 104