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Trial record 96 of 906 for:    Lupus

A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT02975336
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE)

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Placebo Drug: M2951 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)
Actual Study Start Date : January 4, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Placebo Comparator: Placebo: Double-Blind Treatment Period Drug: Placebo
Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period.

Experimental: M2951: Double-Blind Treatment Period Drug: M2951
M2951 low dose will be administered for 52 weeks in double-blind treatment period.
Other Name: Evobrutinib

Experimental: M2951 Mid Dose: Double-Blind Treatment Period Drug: M2951
M2951 mid dose will be administered for 52 weeks in double-blind treatment period.
Other Name: Evobrutinib

Experimental: M2951 High dose: Double-Blind Treatment Period Drug: M2951
M2951 high dose will be administered for 52 weeks.
Other Name: Evobrutinib

Experimental: M2951: Open-Label Extension Period Drug: M2951
M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day.
Other Name: Evobrutinib




Primary Outcome Measures :
  1. Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): All Subjects [ Time Frame: Week 52 ]
  2. Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): High Disease Activity (HDA) Subgroup Subjects [ Time Frame: Week 52 ]
  3. Occurrences of Subjects With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: Baseline up to Week 56 ]
  4. Occurrences of Treatment-emergent Adverse Events (TEAEs) According to Severity [ Time Frame: Baseline up to Week 56 ]
  5. Number of Subjects With Clinically Significant Vital signs, Electrocardiogram (ECG) and Laboratory Abnormalities [ Time Frame: Baseline up to Week 56 ]
  6. Serum Total Immunoglobulin (Ig) levels [ Time Frame: up to Week 56 ]
  7. Total B Cell Counts [ Time Frame: up to Week 56 ]
  8. Change From Baseline to Week 56 in Serum total Immunoglobulin (Ig) levels [ Time Frame: Baseline, up to Week 56 ]
  9. Change From Baseline to Week 56 in Total B Cell Counts [ Time Frame: Baseline, up to Week 56 ]

Secondary Outcome Measures :
  1. Time to First Severe Flare [ Time Frame: Baseline up to Week 52 ]
  2. Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup [ Time Frame: Week 52 ]
  3. Number of Subjects With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): Serologically Active Subgroup [ Time Frame: Week 52 ]
  4. Time to First Flare [ Time Frame: Baseline up to Week 52 ]
  5. Flare-free Status [ Time Frame: Week 52 ]
  6. Annualized Flare Rate [ Time Frame: Baseline up to Week 52 ]
  7. Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of <= 2 at Week 52 [ Time Frame: Week 52 ]
  8. Low Disease Activity Status, Defined by Clinical SLEDAI-2K Score of <= 2 at Week 52 [ Time Frame: Week 52 ]
  9. Change From Baseline in SLEDAI-2K Score by Visit [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  10. Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score by Visit [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  11. Number of Subjects With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  12. Change From Baseline in BILAG-2004 by Visit [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  13. Change From Baseline in Physician's Global Assessment (PGA) by Visit [ Time Frame: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 ]
  14. Change From Baseline in Study 36-Item Short Form Health Survey version 2 (SF-36v2) Physical Component Score and Mental Component Scores by Visit [ Time Frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52 ]
  15. Change From Baseline in EuroQoL 5 Dimension 5 Levels (EQ-5D-5L) Scale Score by Visit [ Time Frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52 ]
  16. Change From Baseline in Lupus Quality of Life (LupusQoL) Scale Score by Visit [ Time Frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52 ]
  17. Patient Global Impression of Change (PGIC) Scale Score by Visit [ Time Frame: Week 4, 8, 12, 16, 24, 32, 40, and 52 ]
  18. Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit [ Time Frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52 ]
  19. Number of Subjects With Change From Baseline in Prednisone-equivalent Corticosteroid (CS) dose by >=25% to a dose of <=7.5 mg/day, with no BILAG A or 2B Flare in Disease Activity [ Time Frame: up to Week 52 ]
  20. Change From Baseline to Week 52 in Prednisone-equivalent CS daily dose [ Time Frame: Baseline, up to Week 52 ]
  21. Change From Baseline to Week 52 in Prednisone-equivalent CS Daily Dose of 0 to < 25%, 25% to 50%, > 50%, or an increase [ Time Frame: Baseline, up to Week 52 ]
  22. Cumulative Prednisone-equivalent CS dose [ Time Frame: Baseline up to Week 52 ]
  23. Clinically Meaningful Change in CS Dose From Baseline [ Time Frame: up to Week 52 ]
  24. Number of Subjects with a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): all subject [ Time Frame: Week 52 ]
  25. Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): all subject [ Time Frame: Week 52 ]
  26. Number of Subjects with a Sustained Reduction of OCS Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): HDA subgroup [ Time Frame: Week 52 ]
  27. Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6): HDA subgroup [ Time Frame: Week 52 ]
  28. Number of Subjects with a Sustained Reduction of OCS Dose to 7.5 milligrams prednisone equivalent per day or less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup [ Time Frame: Week 52 ]
  29. Number of Subjects with a Sustained Reduction of OCS Dose less than or equal to (<=) Day 1 dose With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4): Serologically Active Subgroup [ Time Frame: Week 52 ]
  30. Lupus Low Disease Activity State [ Time Frame: Week 52 ]
    Lupus low disease activity state will be measured as: SLEDAI-2K <= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent <= 7.5 milligram per day; Unchanged background immunosuppressive therapy.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible male and female subjects, aged 18 to 75 years
  • Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
  • SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
  • And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
  • Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

  • Subjects are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
  • Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
  • Acutely worsened renal function
  • Central nervous system SLE
  • Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (>) 30 mg daily prednisone equivalent
  • Use of injectable corticosteroids, or change in dose of corticosteroids.
  • Other protocol defined exclusion criteria could apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975336


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Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02975336     History of Changes
Other Study ID Numbers: MS200527-0018
2016-002950-19 ( EudraCT Number )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Systemic Lupus Erythematosus
M2951
Placebo
Dose response
Oral Corticosteroids
Safety
Efficacy
Autoimmune And Inflammatory Disorders
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases