Phase 2 N=182 Randomized Quadruple-blind Treatment

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

Systemic Lupus Erythematosus (SLE)

Bottom Line

View on ClinicalTrials.gov: NCT02804763 ↗

Enrolled (actual)

182

Serious AEs

12.1%

Results posted

Jun 2021

Primary outcome: Primary: 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 — 0; 0; 0; 0 percentage of participants — p==0.0727

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Dapirolizumab pegol (DZP) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB Biopharma S.P.R.L.
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	0; 0; 0; 0	=0.0727
SECONDARY The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24	37.2; 48.8; 54.5; 52.2	=0.2699
SECONDARY Percentage of Participants With at Least One Adverse Events (AEs)	66.7; 66.7; 82.2; 74.5	—
SECONDARY Percentage of Participants With a Serious Adverse Event (SAE)	13.3; 11.1; 13.3; 10.6	—
SECONDARY Percentage of Participants With at Least One Adverse Events (AEs) of Interest	24.4; 26.7; 28.9; 25.5	—
SECONDARY Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)	8.9; 0; 4.4; 4.3	—
SECONDARY Mean Change From Baseline in Systolic Blood Pressure	3.3; 5.1; 0.7; 3.2; 0.6; 1.0	—
SECONDARY Mean Change From Baseline in Diastolic Blood Pressure	2.1; 1.4; 1.5; 2.4; -0.7; -1.5	—
SECONDARY Mean Change From Baseline in Pulse Rate	-0.2; 0.2; 2.3; -0.9; 1.7; 1.5	—
SECONDARY Mean Change From Baseline in Temperature	-0.1; 0.0; 0.1; 0.0; -0.1; 0.0	—
SECONDARY Mean Change From Baseline in Weight	0.0; 0.2; 0.4; 0.3; 0.3; 0.6	—
SECONDARY Mean Change From Baseline in Height	NA; NA; NA; NA	—
SECONDARY Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings	8; 11; 6; 6; 11; 12	—
SECONDARY Mean Change From Baseline in Hemoglobin	0.4; -1.8; -0.7; -0.7; -1.0; -0.7	—
SECONDARY Mean Change From Baseline in Hematocrit	0.42; -0.25; -0.32; 0.00; -0.46; -0.17	—
SECONDARY Mean Change From Baseline in Erythrocytes	-0.004; -0.035; -0.032; -0.028; -0.080; -0.018	—
SECONDARY Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume	1.01; 0.24; -0.09; 0.45; 0.60; 0.08	—
SECONDARY Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration	-2.3; -2.6; 0.7; -1.9; 1.4; -0.9	—
SECONDARY Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin	0.12; -0.18; 0.04; 0.00; 0.31; -0.06	—
SECONDARY Mean Change From Baseline in Leukocytes	0.34; 0.27; 0.49; 0.20; 0.10; 0.27	—
SECONDARY Mean Change From Baseline in Basophils	0.01; 0.02; 0.00; 0.00; 0.01; 0.00	—
SECONDARY Mean Change From Baseline in Basophils/Leukocytes	-0.05; 0.02; -0.05; -0.03; 0.03; -0.06	—
SECONDARY Mean Change From Baseline in Eosinophils	-0.01; 0.01; 0.00; -0.01; -0.01; -0.01	—
SECONDARY Mean Change From Baseline in Eosinophils/Leukocytes	-0.19; 0.07; -0.18; -0.29; -0.32; -0.05	—
SECONDARY Mean Change From Baseline in Lymphocytes	-0.03; 0.05; 0.16; 0.24; -0.04; -0.01	—
SECONDARY Mean Change From Baseline in Lymphocytes/Leukocytes	-1.88; 0.19; 1.18; 2.61; -0.88; -1.02	—
SECONDARY Mean Change From Baseline in Monocytes	-0.01; 0.01; 0.05; 0.01; 0.01; 0.04	—
SECONDARY Mean Change From Baseline in Monocytes/Leukocytes	-0.87; -0.07; 0.23; -0.37; 0.26; 0.27	—
SECONDARY Mean Change From Baseline in Neutrophils	0.28; 0.26; 0.17; -0.01; 0.07; 0.27	—
SECONDARY Mean Change From Baseline in Neutrophils/Leukocytes	2.99; -0.21; -1.20; -1.93; 0.91; 0.89	—
SECONDARY Mean Change From Baseline in Platelets	5.9; 10.0; 1.4; -1.0; -5.2; 0.0	—
SECONDARY Mean Change From Baseline in Cluster of Differentiation 3 (CD3)	33.0; 77.7; 106.6; 126.9; -30.6; -47.7	—
SECONDARY Mean Change From Baseline in CD3/Lymphocytes	-0.7; -0.9; -2.0; -0.2; -2.1; -0.5	—
SECONDARY Mean Change From Baseline in Cluster of Differentiation 19 (CD19)	9.6; 12.3; 24.8; 63.4; -2.8; -31.2	—
SECONDARY Mean Change From Baseline in CD19/Lymphocytes	-0.3; -0.1; 1.0; 1.5; 0.0; -0.5	—
SECONDARY Mean Change From Baseline in Aspartate Aminotransferase	-0.5; 0.2; 4.3; 0.0; -0.1; 0.2	—
SECONDARY Mean Change From Baseline in Alanine Aminotransferase	2.4; 2.6; 0.5; -0.1; 0.8; -0.5	—
SECONDARY Mean Change From Baseline in Alkaline Phosphatase	1.8; 2.4; 1.5; -3.6; -1.7; 0.7	—
SECONDARY Mean Change From Baseline in Gamma Glutamyl Transferase	0.3; 2.0; 8.8; -3.4; 2.1; -1.3	—
SECONDARY Mean Change From Baseline in Bilirubin	0.35; -0.48; 0.28; -0.78; 0.07; -0.18	—
SECONDARY Mean Change From Baseline in Direct Bilirubin	0.03; -0.06; 0.09; -0.24; 0.10; 0.03	—
SECONDARY Mean Change From Baseline in Lactate Dehydrogenase	-3.3; -7.8; -5.9; -12.8; -3.0; -3.7	—
SECONDARY Mean Change From Baseline in Creatinine	0.9; -0.1; 1.5; 0.6; -0.8; -0.2	—
SECONDARY Mean Change From Baseline in Urea Nitrogen	0.28; -0.09; -0.05; -0.02; -0.07; -0.33	—
SECONDARY Mean Change From Baseline in Sodium	-0.1; -0.4; 0.1; 0.0; -0.3; -0.6	—
SECONDARY Mean Change From Baseline in Potassium	0.04; 0.15; 0.00; -0.03; 0.06; 0.08	—
SECONDARY Mean Change From Baseline in Calcium	0.008; -0.001; 0.004; -0.008; 0.007; -0.018	—
SECONDARY Mean Change From Baseline in Phosphate	0.044; 0.032; -0.047; 0.033; -0.004; -0.029	—
SECONDARY Mean Change From Baseline in Cholesterol	0.00; -0.07; -0.06; -0.19; -0.08; -0.03	—
SECONDARY Mean Change From Baseline in Triglycerides	-0.176; 0.046; 0.110; 0.183; -0.189; -0.004	—
SECONDARY Mean Change From Baseline in Protein	-0.2; -1.2; -1.0; -1.1; -1.5; -1.6	—
SECONDARY Mean Change From Baseline in Albumin	0.1; -0.4; -0.5; -0.5; -0.5; -0.4	—
SECONDARY Mean Change From Baseline in Glucose	0.18; 0.26; 0.09; 0.13; 0.04; 0.03	—
SECONDARY Mean Change From Baseline in Lipase, Pancreatic	-1.1; 2.2; 0.1; -0.2; -2.1; 0.9	—
SECONDARY Mean Change From Baseline in Creatine Kinase	-3.0; -2.2; -2.2; 0.1; 29.6; -6.2	—
SECONDARY Mean Change From Baseline in pH	-0.01; 0.03; -0.07; 0.15; 0.10; 0.15	—
SECONDARY Mean Change From Baseline in Erythrocytes (/HPF)	-6.8; 0.1; 0.2; 0.9; -8.7; -0.8	—
SECONDARY Mean Change From Baseline in Leukocytes (/HPF)	-0.1; -1.4; -0.8; 2.9; -0.2; -0.6	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02804763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.