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

Primary Purpose

Systemic Lupus Erythematosus (SLE)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Dapirolizumab pegol (DZP)
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus (SLE) focused on measuring Systemic Lupus Erythematosus (SLE), Dapirolizumab Pegol (DZP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sl0023 312
  • Sl0023 307
  • Sl0023 309
  • Sl0023 323
  • Sl0023 311
  • Sl0023 314
  • Sl0023 302
  • Sl0023 326
  • Sl0023 304
  • Sl0023 322
  • Sl0023 301
  • Sl0023 321
  • Sl0023 319
  • Sl0023 310
  • Sl0023 324
  • Sl0023 327
  • Sl0023 320
  • Sl0023 306
  • Sl0023 313
  • Sl0023 305
  • Sl0023 315
  • Sl0023 308
  • Sl0023 317
  • Sl0023 303
  • Sl0023 328
  • Sl0023 101
  • Sl0023 102
  • Sl0023 202
  • Sl0023 203
  • Sl0023 201
  • Sl0023 204
  • Sl0023 213
  • Sl0023 212
  • Sl0023 214
  • Sl0023 216
  • Sl0023 211
  • Sl0023 215
  • Sl0023 341
  • Sl0023 113
  • Sl0023 124
  • Sl0023 225
  • Sl0023 224
  • Sl0023 221
  • Sl0023 222
  • Sl0023 232
  • Sl0023 231
  • Sl0023 234
  • Sl0023 235
  • Sl0023 133
  • Sl0023 136
  • Sl0023 131
  • Sl0023 134
  • Sl0023 135
  • Sl0023 138
  • Sl0023 146
  • Sl0023 142
  • Sl0023 144
  • Sl0023 141
  • Sl0023 157
  • Sl0023 156
  • Sl0023 152
  • Sl0023 155
  • Sl0023 151
  • Sl0023 153
  • Sl0023 161
  • Sl0023 162
  • Sl0023 166
  • Sl0023 172
  • Sl0023 175
  • Sl0023 171
  • Sl0023 173

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

DZP dose 1

DZP dose 2

DZP dose 3

Arm Description

Placebo in a specified sequence for a total of 24 weeks

Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks

Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks

Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks

Outcomes

Primary Outcome Measures

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: 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. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 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). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.

Secondary Outcome Measures

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: 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. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 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). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
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.
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.
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.
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
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.
Mean Change From Baseline in Systolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Diastolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Pulse Rate
Pulse Rate was measured in beats per minute (beats/min).
Mean Change From Baseline in Temperature
Temperature was measured in Grad Celsius (°C).
Mean Change From Baseline in Weight
Weight was measured in kilograms (kg).
Mean Change From Baseline in Height
Height was measured in centimeters (cm).
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Mean Change From Baseline in Hemoglobin
Hemoglobin was measured in grams per liter (g/L).
Mean Change From Baseline in Hematocrit
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Mean Change From Baseline in Erythrocytes
Erythrocytes was measured in number of erythrocytes per liter (10^12/L).
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Mean Change From Baseline in Leukocytes
Leukocytes was measured in number of leukocytes per liter (10^9/L).
Mean Change From Baseline in Basophils
Basophils was measured in number of basophils per liter (10^9/L).
Mean Change From Baseline in Basophils/Leukocytes
Basophils/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Eosinophils
Eosinophils was measured in number of eosinophils per liter (10^9/L).
Mean Change From Baseline in Eosinophils/Leukocytes
Eosinophils/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Lymphocytes
Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Mean Change From Baseline in Lymphocytes/Leukocytes
Lymphocytes/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Monocytes
Monocytes was measured in number of monocytes per liter (10^9/L).
Mean Change From Baseline in Monocytes/Leukocytes
Monocytes/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Neutrophils
Neutrophils was measured in number of neutrophils per liter (10^9/L).
Mean Change From Baseline in Neutrophils/Leukocytes
Neutrophils/Leukocytes was measured in percentages (%).
Mean Change From Baseline in Platelets
Platelets was measured in number of platelets per liter (10^9/L).
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Mean Change From Baseline in CD3/Lymphocytes
CD3/Lymphocytes was measured in percentages (%).
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Mean Change From Baseline in CD19/Lymphocytes
CD19/Lymphocytes was measured in percentages (%).
Mean Change From Baseline in Aspartate Aminotransferase
Aspartate Aminotransferase was measured in units per liter (U/L).
Mean Change From Baseline in Alanine Aminotransferase
Alanine Aminotransferase was measured in units per liter (U/L).
Mean Change From Baseline in Alkaline Phosphatase
Alkaline Phosphatase was measured in units per liter (U/L).
Mean Change From Baseline in Gamma Glutamyl Transferase
Gamma Glutamyl Transferase was measured in units per liter (U/L).
Mean Change From Baseline in Bilirubin
Bilirubin was measured in micromols per liter (µmol/L).
Mean Change From Baseline in Direct Bilirubin
Direct Bilirubin was measured in micromols per liter (µmol/L).
Mean Change From Baseline in Lactate Dehydrogenase
Lactate Dehydrogenase was measured in units per liter (U/L).
Mean Change From Baseline in Creatinine
Creatinine was measured in micromols per liter (µmol/L).
Mean Change From Baseline in Urea Nitrogen
Urea Nitrogen was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Sodium
Sodium was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Potassium
Potassium was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Calcium
Calcium was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Phosphate
Phosphate was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Cholesterol
Cholesterol was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Triglycerides
Triglycerides was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Protein
Protein was measured in grams per liter (g/L).
Mean Change From Baseline in Albumin
Albumin was measured in grams per liter (g/L).
Mean Change From Baseline in Glucose
Glucose was measured in millimoles per liter (mmol/L).
Mean Change From Baseline in Lipase, Pancreatic
Lipase, Pancreatic was measured in units per liter (U/L).
Mean Change From Baseline in Creatine Kinase
Creatine Kinase was measured in units per liter (U/L).
Mean Change From Baseline in pH
Mean Change From Baseline in Erythrocytes (/HPF)
Mean Change From Baseline in Leukocytes (/HPF)

Full Information

First Posted
June 14, 2016
Last Updated
June 7, 2021
Sponsor
UCB Biopharma S.P.R.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02804763
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
November 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE)
Keywords
Systemic Lupus Erythematosus (SLE), Dapirolizumab Pegol (DZP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in a specified sequence for a total of 24 weeks
Arm Title
DZP dose 1
Arm Type
Experimental
Arm Description
Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks
Arm Title
DZP dose 2
Arm Type
Experimental
Arm Description
Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks
Arm Title
DZP dose 3
Arm Type
Experimental
Arm Description
Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for infusion, 0,9% saline
Intervention Type
Drug
Intervention Name(s)
Dapirolizumab pegol (DZP)
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
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
Description
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: 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. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 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). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24
Description
BICLA response was defined as meeting all of the following criteria: 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. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 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). No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
Time Frame
Week 24
Title
Percentage of Participants With at Least One Adverse Events (AEs)
Description
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.
Time Frame
From Baseline (Week 1) until end of the study (Week 48)
Title
Percentage of Participants With a Serious Adverse Event (SAE)
Description
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)
Title
Percentage of Participants With at Least One Adverse Events (AEs) of Interest
Description
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)
Title
Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)
Description
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.
Time Frame
From Baseline (Week 1) until end of the study (Week 48)
Title
Mean Change From Baseline in Systolic Blood Pressure
Description
Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Diastolic Blood Pressure
Description
Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Pulse Rate
Description
Pulse Rate was measured in beats per minute (beats/min).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Temperature
Description
Temperature was measured in Grad Celsius (°C).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Weight
Description
Weight was measured in kilograms (kg).
Time Frame
Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20
Title
Mean Change From Baseline in Height
Description
Height was measured in centimeters (cm).
Time Frame
From Baseline (Week 1) to Week 48
Title
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings
Description
Twelve-lead ECG assessments should have been performed prior to dosing (if applicable) and prior to obtaining pharmacokinetic (PK) or other laboratory samples. Electrocardiograms were recorded digitally and read by the Investigator for recording in the electronic Case Report Form (eCRF).
Time Frame
Screening, Week 4, Week 24, Week 28 and Week 48
Title
Mean Change From Baseline in Hemoglobin
Description
Hemoglobin was measured in grams per liter (g/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Hematocrit
Description
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Erythrocytes
Description
Erythrocytes was measured in number of erythrocytes per liter (10^12/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume
Description
Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Description
Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
Description
Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Leukocytes
Description
Leukocytes was measured in number of leukocytes per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Basophils
Description
Basophils was measured in number of basophils per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Basophils/Leukocytes
Description
Basophils/Leukocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Eosinophils
Description
Eosinophils was measured in number of eosinophils per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Eosinophils/Leukocytes
Description
Eosinophils/Leukocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Lymphocytes
Description
Lymphocytes was measured in number of lymphocytes per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Lymphocytes/Leukocytes
Description
Lymphocytes/Leukocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Monocytes
Description
Monocytes was measured in number of monocytes per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Monocytes/Leukocytes
Description
Monocytes/Leukocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Neutrophils
Description
Neutrophils was measured in number of neutrophils per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Neutrophils/Leukocytes
Description
Neutrophils/Leukocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Platelets
Description
Platelets was measured in number of platelets per liter (10^9/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Cluster of Differentiation 3 (CD3)
Description
Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in CD3/Lymphocytes
Description
CD3/Lymphocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Cluster of Differentiation 19 (CD19)
Description
Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in CD19/Lymphocytes
Description
CD19/Lymphocytes was measured in percentages (%).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Aspartate Aminotransferase
Description
Aspartate Aminotransferase was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Alanine Aminotransferase
Description
Alanine Aminotransferase was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Alkaline Phosphatase
Description
Alkaline Phosphatase was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Gamma Glutamyl Transferase
Description
Gamma Glutamyl Transferase was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Bilirubin
Description
Bilirubin was measured in micromols per liter (µmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Direct Bilirubin
Description
Direct Bilirubin was measured in micromols per liter (µmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Lactate Dehydrogenase
Description
Lactate Dehydrogenase was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Creatinine
Description
Creatinine was measured in micromols per liter (µmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Urea Nitrogen
Description
Urea Nitrogen was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Sodium
Description
Sodium was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Potassium
Description
Potassium was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Calcium
Description
Calcium was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Phosphate
Description
Phosphate was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Cholesterol
Description
Cholesterol was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Triglycerides
Description
Triglycerides was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Protein
Description
Protein was measured in grams per liter (g/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Albumin
Description
Albumin was measured in grams per liter (g/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Glucose
Description
Glucose was measured in millimoles per liter (mmol/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Lipase, Pancreatic
Description
Lipase, Pancreatic was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Creatine Kinase
Description
Creatine Kinase was measured in units per liter (U/L).
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in pH
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Erythrocytes (/HPF)
Time Frame
From Baseline (Week 1) to Week 48
Title
Mean Change From Baseline in Leukocytes (/HPF)
Time Frame
From Baseline (Week 1) to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Sl0023 312
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Sl0023 307
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Sl0023 309
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Sl0023 323
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Sl0023 311
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Sl0023 314
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Sl0023 302
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Sl0023 326
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Sl0023 304
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Sl0023 322
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Sl0023 301
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Sl0023 321
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sl0023 319
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Sl0023 310
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Sl0023 324
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Sl0023 327
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Sl0023 320
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Sl0023 306
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87104
Country
United States
Facility Name
Sl0023 313
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Sl0023 305
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Facility Name
Sl0023 315
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Sl0023 308
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Sl0023 317
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Sl0023 303
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Sl0023 328
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Sl0023 101
City
Plovdiv
Country
Bulgaria
Facility Name
Sl0023 102
City
Plovdiv
Country
Bulgaria
Facility Name
Sl0023 202
City
Providencia
Country
Chile
Facility Name
Sl0023 203
City
Providencia
Country
Chile
Facility Name
Sl0023 201
City
Puerto Varas
Country
Chile
Facility Name
Sl0023 204
City
Vina del Mar
Country
Chile
Facility Name
Sl0023 213
City
Barranquilla
Country
Colombia
Facility Name
Sl0023 212
City
Bogotá
Country
Colombia
Facility Name
Sl0023 214
City
Bogotá
Country
Colombia
Facility Name
Sl0023 216
City
Bucaramanga
Country
Colombia
Facility Name
Sl0023 211
City
Chía
Country
Colombia
Facility Name
Sl0023 215
City
Medellín
Country
Colombia
Facility Name
Sl0023 341
City
Hannover
Country
Germany
Facility Name
Sl0023 113
City
Leipzig
Country
Germany
Facility Name
Sl0023 124
City
Debrecen
Country
Hungary
Facility Name
Sl0023 225
City
Guadalajara
Country
Mexico
Facility Name
Sl0023 224
City
León
Country
Mexico
Facility Name
Sl0023 221
City
Mexico
Country
Mexico
Facility Name
Sl0023 222
City
San Luis Potosí
Country
Mexico
Facility Name
Sl0023 232
City
Arequipa
Country
Peru
Facility Name
Sl0023 231
City
Lima
Country
Peru
Facility Name
Sl0023 234
City
Lima
Country
Peru
Facility Name
Sl0023 235
City
Lima
Country
Peru
Facility Name
Sl0023 133
City
Bytom
Country
Poland
Facility Name
Sl0023 136
City
Lublin
Country
Poland
Facility Name
Sl0023 131
City
Poznan
Country
Poland
Facility Name
Sl0023 134
City
Sosnowiec
Country
Poland
Facility Name
Sl0023 135
City
Warszawa
Country
Poland
Facility Name
Sl0023 138
City
Łódź
Country
Poland
Facility Name
Sl0023 146
City
Brasov
Country
Romania
Facility Name
Sl0023 142
City
Bucuresti
Country
Romania
Facility Name
Sl0023 144
City
Cluj-Napoca
Country
Romania
Facility Name
Sl0023 141
City
Galati
Country
Romania
Facility Name
Sl0023 157
City
Kazan
Country
Russian Federation
Facility Name
Sl0023 156
City
Kemerovo
Country
Russian Federation
Facility Name
Sl0023 152
City
Saint Petersburg
Country
Russian Federation
Facility Name
Sl0023 155
City
Voronezh
Country
Russian Federation
Facility Name
Sl0023 151
City
Yaroslavl'
Country
Russian Federation
Facility Name
Sl0023 153
City
Yekaterinburg
Country
Russian Federation
Facility Name
Sl0023 161
City
Barcelona
Country
Spain
Facility Name
Sl0023 162
City
Madrid
Country
Spain
Facility Name
Sl0023 166
City
Tenerife
Country
Spain
Facility Name
Sl0023 172
City
Kyiv
Country
Ukraine
Facility Name
Sl0023 175
City
Kyiv
Country
Ukraine
Facility Name
Sl0023 171
City
Odessa
Country
Ukraine
Facility Name
Sl0023 173
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34897375
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.
Results Reference
derived

Learn more about this trial

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

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