Study Stopped
Administrative reasons
TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 23, 2018
May 1, 2018
2.2 years
March 14, 2016
May 21, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number and proportion of treatment responders per SLE Responder Index (SRI)
24 weeks
Adverse Events
24 weeks
Secondary Outcomes (2)
Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)
24 weeks
Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
24 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo to TAB08
TAB08 Dose 1
EXPERIMENTALTAB08 Dose 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theramab LLClead
Study Sites (1)
Federal State Budget Institution "Research Institute of Rheumatology of V.A. Nasonova" Russian Academy of Medical Sciences
Moscow, Russia
Related Publications (1)
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.
PMID: 33687069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniil Nemenov, M.D.
Theramab LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 17, 2016
Study Start
March 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 23, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share