Back to resultsTAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
Primary Purpose
Lupus Erythematosus, Systemic
Status
Terminated
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
TAB08
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
- Active SLE (SLE Disease Activity Index ≥ 6)
- Skin or joint SLE manifestations
Exclusion Criteria:
- Lupus-nephritis and/or central nervous system affection (neuro-lupus)
- Prohibited treatment
- Pregnant or nursing women
- Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
Sites / Locations
- Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
TAB08 Dose 1
TAB08 Dose 2
Arm Description
Placebo to TAB08
Outcomes
Primary Outcome Measures
Number and proportion of treatment responders per SLE Responder Index (SRI)
Adverse Events
Secondary Outcome Measures
Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)
Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02711813
Brief Title
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
Official Title
Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theramab LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether TAB08 may be beneficial compared to placebo in patients with active Systemic Lupus Erythematosus, not adequately controlled with current concomitant treatment. Secondary purpose is to assess efficacy, safety, pharmacokinetic and pharmacodynamic parameters in this study population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to TAB08
Arm Title
TAB08 Dose 1
Arm Type
Experimental
Arm Title
TAB08 Dose 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAB08
Intervention Description
biologic
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number and proportion of treatment responders per SLE Responder Index (SRI)
Time Frame
24 weeks
Title
Adverse Events
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)
Time Frame
24 weeks
Title
Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of Lupus Erythematosus according to American College of Rheumatology (ACR) criteria (4 of 11)
Active SLE (SLE Disease Activity Index ≥ 6)
Skin or joint SLE manifestations
Exclusion Criteria:
Lupus-nephritis and/or central nervous system affection (neuro-lupus)
Prohibited treatment
Pregnant or nursing women
Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniil Nemenov, M.D.
Organizational Affiliation
Theramab LLC
Official's Role
Study Director
Facility Information:
Facility Name
Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
Learn more about this trial
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
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