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Completed

NCT Number: NCT02804763

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sl0023 101, Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Solution for infusion, 0,9% saline

Dapirolizumab pegol (DZP)

Drug

Solution for infusion

Primary outcomes

  1. 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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

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

    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.

  3. Percentage of Participants With a Serious Adverse Event (SAE)

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

    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.

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

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

    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.

  5. 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)

    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.

  6. Mean Change From Baseline in Systolic Blood Pressure

    Time frame: From Baseline (Week 1) to Week 48

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

  7. Mean Change From Baseline in Diastolic Blood Pressure

    Time frame: From Baseline (Week 1) to Week 48

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

  8. Mean Change From Baseline in Pulse Rate

    Time frame: From Baseline (Week 1) to Week 48

    Pulse Rate was measured in beats per minute (beats/min).

  9. Mean Change From Baseline in Temperature

    Time frame: From Baseline (Week 1) to Week 48

    Temperature was measured in Grad Celsius (°C).

  10. Mean Change From Baseline in Weight

    Time frame: Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20

    Weight was measured in kilograms (kg).

  11. Mean Change From Baseline in Height

    Time frame: From Baseline (Week 1) to Week 48

    Height was measured in centimeters (cm).

  12. Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings

    Time frame: Screening, Week 4, Week 24, Week 28 and Week 48

    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).

  13. Mean Change From Baseline in Hemoglobin

    Time frame: From Baseline (Week 1) to Week 48

    Hemoglobin was measured in grams per liter (g/L).

  14. Mean Change From Baseline in Hematocrit

    Time frame: From Baseline (Week 1) to Week 48

    Hematocrit was measured in volume percentage (%) of red blood cells in blood.

  15. Mean Change From Baseline in Erythrocytes

    Time frame: From Baseline (Week 1) to Week 48

    Erythrocytes was measured in number of erythrocytes per liter (10^12/L).

  16. Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume

    Time frame: From Baseline (Week 1) to Week 48

    Erythrocytes Mean Corpuscular Volume was measured in femtolitres (fL).

  17. Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration

    Time frame: From Baseline (Week 1) to Week 48

    Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration was measured in grams per liter (g/L).

  18. Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin

    Time frame: From Baseline (Week 1) to Week 48

    Erythrocytes Mean Corpuscular Hemoglobin was measured in picograms (pg).

  19. Mean Change From Baseline in Leukocytes

    Time frame: From Baseline (Week 1) to Week 48

    Leukocytes was measured in number of leukocytes per liter (10^9/L).

  20. Mean Change From Baseline in Basophils

    Time frame: From Baseline (Week 1) to Week 48

    Basophils was measured in number of basophils per liter (10^9/L).

  21. Mean Change From Baseline in Basophils/Leukocytes

    Time frame: From Baseline (Week 1) to Week 48

    Basophils/Leukocytes was measured in percentages (%).

  22. Mean Change From Baseline in Eosinophils

    Time frame: From Baseline (Week 1) to Week 48

    Eosinophils was measured in number of eosinophils per liter (10^9/L).

  23. Mean Change From Baseline in Eosinophils/Leukocytes

    Time frame: From Baseline (Week 1) to Week 48

    Eosinophils/Leukocytes was measured in percentages (%).

  24. Mean Change From Baseline in Lymphocytes

    Time frame: From Baseline (Week 1) to Week 48

    Lymphocytes was measured in number of lymphocytes per liter (10^9/L).

  25. Mean Change From Baseline in Lymphocytes/Leukocytes

    Time frame: From Baseline (Week 1) to Week 48

    Lymphocytes/Leukocytes was measured in percentages (%).

  26. Mean Change From Baseline in Monocytes

    Time frame: From Baseline (Week 1) to Week 48

    Monocytes was measured in number of monocytes per liter (10^9/L).

  27. Mean Change From Baseline in Monocytes/Leukocytes

    Time frame: From Baseline (Week 1) to Week 48

    Monocytes/Leukocytes was measured in percentages (%).

  28. Mean Change From Baseline in Neutrophils

    Time frame: From Baseline (Week 1) to Week 48

    Neutrophils was measured in number of neutrophils per liter (10^9/L).

  29. Mean Change From Baseline in Neutrophils/Leukocytes

    Time frame: From Baseline (Week 1) to Week 48

    Neutrophils/Leukocytes was measured in percentages (%).

  30. Mean Change From Baseline in Platelets

    Time frame: From Baseline (Week 1) to Week 48

    Platelets was measured in number of platelets per liter (10^9/L).

  31. Mean Change From Baseline in Cluster of Differentiation 3 (CD3)

    Time frame: From Baseline (Week 1) to Week 48

    Cluster of differentiation 3 (CD3) was measured in cells per microliter (cells/µL).

  32. Mean Change From Baseline in CD3/Lymphocytes

    Time frame: From Baseline (Week 1) to Week 48

    CD3/Lymphocytes was measured in percentages (%).

  33. Mean Change From Baseline in Cluster of Differentiation 19 (CD19)

    Time frame: From Baseline (Week 1) to Week 48

    Cluster of differentiation 19 (CD19) was measured in cells per microliter (cells/µL).

  34. Mean Change From Baseline in CD19/Lymphocytes

    Time frame: From Baseline (Week 1) to Week 48

    CD19/Lymphocytes was measured in percentages (%).

  35. Mean Change From Baseline in Aspartate Aminotransferase

    Time frame: From Baseline (Week 1) to Week 48

    Aspartate Aminotransferase was measured in units per liter (U/L).

  36. Mean Change From Baseline in Alanine Aminotransferase

    Time frame: From Baseline (Week 1) to Week 48

    Alanine Aminotransferase was measured in units per liter (U/L).

  37. Mean Change From Baseline in Alkaline Phosphatase

    Time frame: From Baseline (Week 1) to Week 48

    Alkaline Phosphatase was measured in units per liter (U/L).

  38. Mean Change From Baseline in Gamma Glutamyl Transferase

    Time frame: From Baseline (Week 1) to Week 48

    Gamma Glutamyl Transferase was measured in units per liter (U/L).

  39. Mean Change From Baseline in Bilirubin

    Time frame: From Baseline (Week 1) to Week 48

    Bilirubin was measured in micromols per liter (µmol/L).

  40. Mean Change From Baseline in Direct Bilirubin

    Time frame: From Baseline (Week 1) to Week 48

    Direct Bilirubin was measured in micromols per liter (µmol/L).

  41. Mean Change From Baseline in Lactate Dehydrogenase

    Time frame: From Baseline (Week 1) to Week 48

    Lactate Dehydrogenase was measured in units per liter (U/L).

  42. Mean Change From Baseline in Creatinine

    Time frame: From Baseline (Week 1) to Week 48

    Creatinine was measured in micromols per liter (µmol/L).

  43. Mean Change From Baseline in Urea Nitrogen

    Time frame: From Baseline (Week 1) to Week 48

    Urea Nitrogen was measured in millimoles per liter (mmol/L).

  44. Mean Change From Baseline in Sodium

    Time frame: From Baseline (Week 1) to Week 48

    Sodium was measured in millimoles per liter (mmol/L).

  45. Mean Change From Baseline in Potassium

    Time frame: From Baseline (Week 1) to Week 48

    Potassium was measured in millimoles per liter (mmol/L).

  46. Mean Change From Baseline in Calcium

    Time frame: From Baseline (Week 1) to Week 48

    Calcium was measured in millimoles per liter (mmol/L).

  47. Mean Change From Baseline in Phosphate

    Time frame: From Baseline (Week 1) to Week 48

    Phosphate was measured in millimoles per liter (mmol/L).

  48. Mean Change From Baseline in Cholesterol

    Time frame: From Baseline (Week 1) to Week 48

    Cholesterol was measured in millimoles per liter (mmol/L).

  49. Mean Change From Baseline in Triglycerides

    Time frame: From Baseline (Week 1) to Week 48

    Triglycerides was measured in millimoles per liter (mmol/L).

  50. Mean Change From Baseline in Protein

    Time frame: From Baseline (Week 1) to Week 48

    Protein was measured in grams per liter (g/L).

  51. Mean Change From Baseline in Albumin

    Time frame: From Baseline (Week 1) to Week 48

    Albumin was measured in grams per liter (g/L).

  52. Mean Change From Baseline in Glucose

    Time frame: From Baseline (Week 1) to Week 48

    Glucose was measured in millimoles per liter (mmol/L).

  53. Mean Change From Baseline in Lipase, Pancreatic

    Time frame: From Baseline (Week 1) to Week 48

    Lipase, Pancreatic was measured in units per liter (U/L).

  54. Mean Change From Baseline in Creatine Kinase

    Time frame: From Baseline (Week 1) to Week 48

    Creatine Kinase was measured in units per liter (U/L).

  55. Mean Change From Baseline in pH

    Time frame: From Baseline (Week 1) to Week 48

  56. Mean Change From Baseline in Erythrocytes (/HPF)

    Time frame: From Baseline (Week 1) to Week 48

  57. Mean Change From Baseline in Leukocytes (/HPF)

    Time frame: From Baseline (Week 1) to Week 48

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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