Clinical trial NCT02804763: A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: Systemic Lupus Erythematosus (SLE)
Dapirolizumab Pegol (DZP)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: 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
timeFrame: Week 24
Secondary outcomes:
measure: The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
timeFrame: Week 24
measure: Percentage of Participants With at Least One Adverse Events (AEs)
timeFrame: From Baseline (Week 1) until end of the study (Week 48)
measure: Percentage of Participants With a Serious Adverse Event (SAE)
timeFrame: From Baseline (Week 1) until end of the study (Week 48)
measure: Percentage of Participants With at Least One Adverse Events (AEs) of Interest
timeFrame: From Baseline (Week 1) until end of the study (Week 48)
measure: Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
timeFrame: From Baseline (Week 1) until end of the study (Week 48)
measure: Mean Change From Baseline in Systolic Blood Pressure
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Diastolic Blood Pressure
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Pulse Rate
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Temperature
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Weight
timeFrame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20
measure: Mean Change From Baseline in Height
timeFrame: From Baseline (Week 1) to Week 48
measure: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
timeFrame: Screening, Week 4, Week 24, Week 28 and Week 48
measure: Mean Change From Baseline in Hemoglobin
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Hematocrit
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Erythrocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Leukocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Basophils
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Basophils/Leukocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Eosinophils
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Eosinophils/Leukocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Lymphocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Lymphocytes/Leukocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Monocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Monocytes/Leukocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Neutrophils
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Neutrophils/Leukocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Platelets
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in CD3/Lymphocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in CD19/Lymphocytes
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Aspartate Aminotransferase
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Alanine Aminotransferase
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Alkaline Phosphatase
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Gamma Glutamyl Transferase
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Bilirubin
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Direct Bilirubin
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Lactate Dehydrogenase
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Creatinine
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Urea Nitrogen
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Sodium
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Potassium
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Calcium
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Phosphate
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Cholesterol
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Triglycerides
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Protein
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Albumin
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Glucose
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Lipase, Pancreatic
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Creatine Kinase
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in pH
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Erythrocytes (/HPF)
timeFrame: From Baseline (Week 1) to Week 48
measure: Mean Change From Baseline in Leukocytes (/HPF)
timeFrame: From Baseline (Week 1) to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sl0023 312
state: Alabama
city: El Cajon
country: United States
facility: Sl0023 307
state: California
city: El Cajon
country: United States
facility: Sl0023 309
state: California
city: Huntington Beach
country: United States
facility: Sl0023 323
state: California
city: Los Angeles
country: United States
facility: Sl0023 311
state: California
city: Thousand Oaks
country: United States
facility: Sl0023 314
state: California
city: Upland
country: United States
facility: Sl0023 302
state: California
city: New Haven
country: United States
facility: Sl0023 326
state: Connecticut
city: Clearwater
country: United States
facility: Sl0023 304
state: Florida
city: DeBary
country: United States
facility: Sl0023 322
state: Florida
city: Miami Lakes
country: United States
facility: Sl0023 301
state: Florida
city: Miami
country: United States
facility: Sl0023 321
state: Florida
city: Palm Harbor
country: United States
facility: Sl0023 319
state: Florida
city: Tampa
country: United States
facility: Sl0023 310
state: Florida
city: Atlanta
country: United States
facility: Sl0023 324
state: Georgia
city: Stockbridge
country: United States
facility: Sl0023 327
state: Georgia
city: Idaho Falls
country: United States
facility: Sl0023 320
state: Idaho
city: Albuquerque
country: United States
facility: Sl0023 306
state: New Mexico
city: Lake Success
country: United States
facility: Sl0023 313
state: New York
city: Oklahoma City
country: United States
facility: Sl0023 305
state: Oklahoma
city: Jackson
country: United States
facility: Sl0023 315
state: Tennessee
city: Memphis
country: United States
facility: Sl0023 308
state: Tennessee
city: Amarillo
country: United States
facility: Sl0023 317
state: Texas
city: Houston
country: United States
facility: Sl0023 303
state: Texas
city: Spokane
country: United States
facility: Sl0023 328
state: Washington
city: Plovdiv
country: Bulgaria
facility: Sl0023 101
city: Plovdiv
country: Bulgaria
facility: Sl0023 102
city: Providencia
country: Chile
facility: Sl0023 202
city: Providencia
country: Chile
facility: Sl0023 203
city: Puerto Varas
country: Chile
facility: Sl0023 201
city: Vina del Mar
country: Chile
facility: Sl0023 204
city: Barranquilla
country: Colombia
facility: Sl0023 213
city: Bogotá
country: Colombia
facility: Sl0023 212
city: Bogotá
country: Colombia
facility: Sl0023 214
city: Bucaramanga
country: Colombia
facility: Sl0023 216
city: Chía
country: Colombia
facility: Sl0023 211
city: Medellín
country: Colombia
facility: Sl0023 215
city: Hannover
country: Germany
facility: Sl0023 341
city: Leipzig
country: Germany
facility: Sl0023 113
city: Debrecen
country: Hungary
facility: Sl0023 124
city: Guadalajara
country: Mexico
facility: Sl0023 225
city: León
country: Mexico
facility: Sl0023 224
city: Mexico
country: Mexico
facility: Sl0023 221
city: San Luis Potosí
country: Mexico
facility: Sl0023 222
city: Arequipa
country: Peru
facility: Sl0023 232
city: Lima
country: Peru
facility: Sl0023 231
city: Lima
country: Peru
facility: Sl0023 234
city: Lima
country: Peru
facility: Sl0023 235
city: Bytom
country: Poland
facility: Sl0023 133
city: Lublin
country: Poland
facility: Sl0023 136
city: Poznan
country: Poland
facility: Sl0023 131
city: Sosnowiec
country: Poland
facility: Sl0023 134
city: Warszawa
country: Poland
facility: Sl0023 135
city: Łódź
country: Poland
facility: Sl0023 138
city: Brasov
country: Romania
facility: Sl0023 146
city: Bucuresti
country: Romania
facility: Sl0023 142
city: Cluj-Napoca
country: Romania
facility: Sl0023 144
city: Galati
country: Romania
facility: Sl0023 141
city: Kazan
country: Russian Federation
facility: Sl0023 157
city: Kemerovo
country: Russian Federation
facility: Sl0023 156
city: Saint Petersburg
country: Russian Federation
facility: Sl0023 152
city: Voronezh
country: Russian Federation
facility: Sl0023 155
city: Yaroslavl'
country: Russian Federation
facility: Sl0023 151
city: Yekaterinburg
country: Russian Federation
facility: Sl0023 153
city: Barcelona
country: Spain
facility: Sl0023 161
city: Madrid
country: Spain
facility: Sl0023 162
city: Tenerife
country: Spain
facility: Sl0023 166
city: Kyiv
country: Ukraine
facility: Sl0023 172
city: Kyiv
country: Ukraine
facility: Sl0023 175
city: Odessa
country: Ukraine
facility: Sl0023 171
city: Vinnytsya
country: Ukraine
facility: Sl0023 173
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Morel T, Cano S, Bartlett SJ, Gordon C, Haier B, Regnault A, Schneider M, Stach C, Cleanthous S. The FATIGUE-PRO: a new patient-reported outcome instrument to quantify fatigue in patients affected by systemic lupus erythematosus. Rheumatology (Oxford). 2022 Aug 3;61(8):3329-3340. doi: 10.1093/rheumatology/keab920.