TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment
Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy
1 other identifier
interventional
9
1 country
1
Brief Summary
Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08 during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled with current therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 15, 2017
February 1, 2017
8 months
May 24, 2016
February 14, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
12 weeks
Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
12 weeks
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
12 weeks
Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
12 weeks
Secondary Outcomes (5)
TAB08 concentrations in peripheral blood
12 weeks
Adverse events frequency, seriousness and severity
16 weeks
Psoriasis Area Severity Index (PASI)
16 weeks
Investigator Global Assessment (IGA)
16 weeks
Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)
12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo to TAB08
TAB08 Dose 1
EXPERIMENTALDrug: TAB08 biologic
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of Vulgar Psoriasis
- Area of Psoriasis skin damage ≥ 10%
- PASI Score ≥ 12
- Score on IGA scale ≥ 3
You may not qualify if:
- Other forms of psoriasis in addition to vulgar
- 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)
Clinical Emergency Hospital of Yaroslavl
Yaroslavl, 150003, Russia
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Daniil Nemenov, M.D.
Theramab LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
June 10, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 15, 2017
Record last verified: 2017-02