A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

UCB Biopharma S.P.R.L.182 enrolled

Overview

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

182

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

PlaceboDRUG

Solution for infusion, 0,9% saline

Dapirolizumab pegol (DZP)DRUG

Solution for infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria * Moderate to severe SLE disease activity * Evidence for at least 1 of the following SLE markers: * Anti-dsDNA antibodies confirmed by central laboratory or * Low complement confirmed by central laboratory or * Antinuclear antibody (ANA) titer of \>= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory * The subject is receiving stable SLE standard-of-care medication Exclusion Criteria: * Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE * Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments. * New or worsening Class III or IV lupus nephritis * Chronic kidney failure stage 3b * 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 * Clinically significant active or latent infection (eg. chronic viral hepatitis B or C) * Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection * Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug * History of thromboembolic events within 12 months of screening * Subject has used protocol defined prohibited medications

Locations (71)

Outcomes

Primary Outcomes

Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24

The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: 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. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as \< 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.

Time frame: Week 24

Secondary Outcomes

The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24

BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: 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. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as \< 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.

Time frame: Week 24

Percentage of Participants With at Least One Adverse Events (AEs)

An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An adverse event (AE) was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that occurred during the study were considered related unless clearly unrelated.

Data from ClinicalTrials.gov

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Sl0023 312

Birmingham, Alabama, United States

Sl0023 307

El Cajon, California, United States

Sl0023 309

El Cajon, California, United States

Sl0023 323

Huntington Beach, California, United States

Sl0023 311

Los Angeles, California, United States

Sl0023 314

Thousand Oaks, California, United States

Sl0023 302

Upland, California, United States

Sl0023 326

New Haven, Connecticut, United States

Sl0023 304

Clearwater, Florida, United States

Sl0023 322

DeBary, Florida, United States

...and 61 more locations

Time frame: From Baseline (Week 1) until end of the study (Week 48)

Percentage of Participants With a Serious Adverse Event (SAE)

A Serious Adverse Event (SAE) must have met 1 or more of the following criteria: * Death * Life threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may have jeopardized the study participant, and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization.

Time frame: From Baseline (Week 1) until end of the study (Week 48)

Percentage of Participants With at Least One Adverse Events (AEs) of Interest

Adverse events of interest (AEOI) were identified by the Investigator based on definitions per protocol, documented on the electronic Case Report Form (eCRF), adequately monitored, and source controlled. AEOI (regardless of seriousness): * Moderate to severe infections, including opportunistic infections and tuberculosis (TB) * Infusion reactions (including hypersensitivity and anaphylaxis) * Thromboembolic events (including but not limited to cardiovascular events, stroke, myocardial infarction, pulmonary embolism, and deep vein thrombosis) * Prespecified neurological events: severe and/or serious headache, positional headache, cranial nerve dysfunction, or signs and symptoms of meningitis (photophobia, neck stiffness) * Malignancies.

Time frame: From Baseline (Week 1) until end of the study (Week 48)

Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)

Time frame: From Baseline (Week 1) until end of the study (Week 48)

Mean Change From Baseline in Systolic Blood Pressure

Blood pressure was measured in millimetre of mercury (mmHg).