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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02711813 |
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Date of registration:
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14/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment
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Scientific title:
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Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02711813 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Daniil Nemenov, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Theramab LLC |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Intervention(s)
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Other: Placebo
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Drug: TAB08
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Primary Outcome(s)
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Number and proportion of treatment responders per SLE Responder Index (SRI)
[Time Frame: 24 weeks]
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Adverse Events
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Area and severity of SLE skin damage by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
[Time Frame: 24 weeks]
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Patient-reportet health outcome assessed by Short Form - 36 questionnaire (SF-36)
[Time Frame: 24 weeks]
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Secondary ID(s)
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TAB08-SLE-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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