PsoriasisPhase 2NCT00782613
Efficacy and Safety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic Plaque Psoriasis
A Phase 2 study testing 4,4-dimethyl-benziso-2H-selenazine in people with Psoriasis, run by Synvista Therapeutics, Inc at 3 sites in Israel.
Trial summary
The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- 4,4-dimethyl-benziso-2H-selenazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesIsrael
- Study dates
- Nov 2008to Mar 2009
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to qualify for entry into the study:
- Men and women between 18 and 75 years old, inclusive.
- Clinical diagnosis of stable, chronic plaque psoriasis for at least 6 months prior to Visit 1.
- In otherwise good general health and free of any disease or physical condition which might impair evaluation of plaque psoriasis.
- Plaque psoriasis treatable area <10% BSA. (Subject palm size is equivalent to 1% of BSA.)
- Have 2 well-matched plaques (target plaques) of approximately 3 to 8 cm by 3 to 8 cm in size in areas on the right and left or front and back, at sites other than the knees, below the knees, elbows, head, face, scalp, palms, and intertriginous areas.
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- A Combined Psoriasis Severity Score (CPSS) > 6 for each target plaque at Visit 1.
- Willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- Able to understand and willing to comply with all study requirements, particularly the regimen for administration of study drug.
- Able to understand and willing to sign the Informed Consent Form.
Who cannot join
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, eg, oral contraceptive agents, intrauterine device (IUD), and barrier method plus spermicide.
- Clinical diagnosis of guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
- Use of emollients or moisturizers on areas to be treated within 24 hours prior to Visits 1 or 2.
- Use of topical antipsoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to Visit 2.
- Received systemic immunomodulatory therapy to treat psoriasis (eg, methotrexate, cyclosporine, alefacept, etanercept, infliximab, efalizumab, adalimumab) within 12 weeks prior to Visit 2.
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- Received phototherapy (including laser), photochemotherapy, or systemic psoriasis therapy (eg, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to Visit 2.
- Recent history (within past 12 months) of alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz distilled spirits).
- History of noncompliance to medical regimens or unwilling to comply with the study protocol.
- Participation in an investigational drug study within 30 days prior to Visit 2.
- Serious or unstable medical or psychological conditions that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Ha'emek Medical Center
Afula
Kaplan Medical Center
Rehovot
Chaim Sheba Medical Center
Tel HaShomer
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Wafety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic
The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
Tertiary objectives will be to provide visual documentation of the improvement of psoriatic plaques treated with ALT-2074 using digital photography, and to determine the extent of systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of blood concentration.
- Conditions
- Psoriasis
- Being tested
- 4,4-dimethyl-benziso-2H-selenazine, Placebo
- Keywords
- Psoriasis, The primary objective of this study will be to evaluate the, efficacy of topical ALT-2074 applied twice daily for 28, days for treatment of chronic plaque psoriasis in adult, subjects., The secondary objective will be to evaluate the safety, of topical ALT-2074 applied twice daily for 28 days for, treatment of chronic plaque psoriasis in adult subjects., Tertiary objectives will be to provide visual documentation, of the improvement of psoriatic plaques treated with, ALT-2074 using digital photography, and to determine the, extent of systemic absorption of topically applied ALT-2074, based on a pharmacokinetic measurement of blood, concentration.
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4,4-dimethyl-benziso-2H-selenazineDrug
ALT-2074 in a 0.5% cream formulation
PlaceboDrug
Placebo in a cream formulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Two psoriatic plaques of similar surface area and severity will be identified for each subject. ALT-2074 will be applied topically twice daily to 1 of the 2 target plaques, and the placebo control to the other plaque for a period of 28 days in amounts sufficient to cover the entire surface area of the target plaque, extending to 1 cm outside of the plaque border. Receives: Drug: 4,4-dimethyl-benziso-2H-selenazine |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Why it stopped: Study has been termination early due to financial contraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synvista Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782613
- Sponsor's protocol ID
- ALT-2074-205
- Status last verified
- Jan 2009
- First submitted
- 29 Oct 2008
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Wafety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic
- ClinicalTrials.gov ID
- NCT00782613
- Acronym / sponsor ID
- ALT-2074-205
- Conditions
- Psoriasis
- Keywords
- Psoriasis, The primary objective of this study will be to evaluate the, efficacy of topical ALT-2074 applied twice daily for 28, days for treatment of chronic plaque psoriasis in adult, subjects., The secondary objective will be to evaluate the safety, of topical ALT-2074 applied twice daily for 28 days for, treatment of chronic plaque psoriasis in adult subjects.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been termination early due to financial contraints.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Synvista Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 31 Oct 2008 (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.
The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
Tertiary objectives will be to provide visual documentation of the improvement of psoriatic plaques treated with ALT-2074 using digital photography, and to determine the extent of systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of blood concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 4,4-dimethyl-benziso-2H-selenazineTwo psoriatic plaques of similar surface area and severity will be identified for each subject. ALT-2074 will be applied topically twice daily to 1 of the 2 target plaques, and the placebo control to the other plaque for a period of 28 days in amounts sufficient to cover the entire surface area of the target plaque, extending to 1 cm outside of the plaque border. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women between 18 and 75 years old, inclusive.
- Clinical diagnosis of stable, chronic plaque psoriasis for at least 6 months prior to Visit 1.
- In otherwise good general health and free of any disease or physical condition which might impair evaluation of plaque psoriasis.
- Plaque psoriasis treatable area <10% BSA. (Subject palm size is equivalent to 1% of BSA.)
- Have 2 well-matched plaques (target plaques) of approximately 3 to 8 cm by 3 to 8 cm in size in areas on the right and left or front and back, at sites other than the knees, below the knees, elbows, head, face, scalp, palms, and intertriginous areas.
Key exclusion criteria (11 listed)
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, eg, oral contraceptive agents, intrauterine device (IUD), and barrier method plus spermicide.
- Clinical diagnosis of guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
- Use of emollients or moisturizers on areas to be treated within 24 hours prior to Visits 1 or 2.
- Use of topical antipsoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to Visit 2.
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 |
|---|---|---|
| 4,4-dimethyl-benziso-2H-selenazineALT-2074 in a 0.5% cream formulation | Drug | 1 |
| PlaceboPlacebo in a cream formulation | Drug | 2 |
Primary outcome
Efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Study has been termination early due to financial contraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4,4-dimethyl-benziso-2H-selenazine in people with Psoriasis, run by Synvista Therapeutics, Inc at 3 sites in Israel.
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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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 phase mean?
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 was stopped early (reason given: Study has been termination early due to financial contraints.). Results are not available in the source record.
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?
Efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects. (time frame: 28 days). 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 30 Jan 2009.