TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment
NCT ID: NCT02796053
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2016-04-30
2016-12-31
Brief Summary
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Detailed Description
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2. To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
3. To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
4. To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
5. To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo to TAB08
Placebo
The Placebo to TAB08 will be administered intravenously, by infusion.
TAB08 Dose 1
Drug: TAB08 biologic
TAB08
The TAB08 will be administered intravenously, by infusion.
Interventions
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TAB08
The TAB08 will be administered intravenously, by infusion.
Placebo
The Placebo to TAB08 will be administered intravenously, by infusion.
Eligibility Criteria
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Inclusion Criteria
* Area of Psoriasis skin damage ≥ 10%
* PASI Score ≥ 12
* Score on IGA scale ≥ 3
Exclusion Criteria
* Prohibited treatment
* Pregnant or nursing women
* Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization
18 Years
70 Years
ALL
No
Sponsors
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Theramab LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Daniil Nemenov, M.D.
Role: STUDY_DIRECTOR
Theramab LLC
Locations
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Clinical Emergency Hospital of Yaroslavl
Yaroslavl, , Russia
Countries
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Other Identifiers
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TAB08-PSO-01
Identifier Type: -
Identifier Source: org_study_id
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