Psoriasis VulgarisPhase 1/2NCT02796053
TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment
A Phase 1/2 study testing TAB08 in people with Psoriasis Vulgaris, run by Theramab LLC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- TAB08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteRussia
- Study dates
- Apr 2016to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Vulgar Psoriasis
- Area of Psoriasis skin damage ≥ 10%
- PASI Score ≥ 12
- Score on IGA scale ≥ 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy
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.
Read the detailed description
- To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood during 12 weeks of TAB08 treatment.
- To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
- To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
- To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
- To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.
- Conditions
- Psoriasis Vulgaris
- Being tested
- TAB08, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAB08Drug
The TAB08 will be administered intravenously, by infusion.
PlaceboOther
The Placebo to TAB08 will be administered intravenously, by infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo to TAB08 Receives: Other: Placebo |
| TAB08 Dose 1 | Experimental | Drug: TAB08 biologic Receives: Drug: TAB08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
Measured: 12 weeks
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
Measured: 12 weeks
Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
Measured: 12 weeks
Secondary outcomes (5)
TAB08 concentrations in peripheral blood
Measured: 12 weeks
Adverse events frequency, seriousness and severity
Measured: 16 weeks
Psoriasis Area Severity Index (PASI)
Measured: 16 weeks
Investigator Global Assessment (IGA)
Measured: 16 weeks
Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theramab LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniil Nemenov, M.D., Study director, Theramab LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796053
- Sponsor's protocol ID
- TAB08-PSO-01
- Status last verified
- Feb 2017
- First submitted
- 24 May 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy
- ClinicalTrials.gov ID
- NCT02796053
- Acronym / sponsor ID
- TAB08-PSO-01
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Theramab LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood during 12 weeks of TAB08 treatment.
- To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
- To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
- To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
- To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo to TAB08 |
| TAB08 Dose 1 | Experimental | Drug: TAB08Drug: TAB08 biologic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Vulgar Psoriasis
- Area of Psoriasis skin damage ≥ 10%
- PASI Score ≥ 12
- Score on IGA scale ≥ 3
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAB08The TAB08 will be administered intravenously, by infusion. | Drug | TAB08 Dose 1 |
| PlaceboThe Placebo to TAB08 will be administered intravenously, by infusion. | Other | Placebo |
Primary outcome
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.
Time frame: 12 weeks
Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
Time frame: 12 weeks
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
Time frame: 12 weeks
Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
Time frame: 12 weeks
5 secondary outcomes
TAB08 concentrations in peripheral blood
Time frame: 12 weeks
Adverse events frequency, seriousness and severity
Time frame: 16 weeks
Psoriasis Area Severity Index (PASI)
Time frame: 16 weeks
Investigator Global Assessment (IGA)
Time frame: 16 weeks
Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniil Nemenov, M.D. study director
Theramab LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAB08 in people with Psoriasis Vulgaris, run by Theramab LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.