PsoriasisPhase 2NCT00995969
CT 327 in the Treatment of Psoriasis Vulgaris
A Phase 2 study testing CT 327 in people with Psoriasis, run by Creabilis SA at 12 sites in 3 countries.
Trial summary
This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- CT 327
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Mar 2010to Jan 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 71 years of age
- Able to give informed consent
- Diagnosis of mild (affecting < 3% BSA) to moderate (affecting < 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each
Who cannot join
- If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
- If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
- Allergy to test drug or excipients
- Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
- Received treatment with systemic or locally acting medications which might counter or influence the study aim
- Presence of major medical illness requiring systemic therapy including cancers
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- Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
- Any clinical relevant ECG abnormality
- Have any clinically significant abnormal clinical laboratory test results at screening
- Received any investigational drug or taking part in any clinical study within three months prior to this study
- History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
- Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Have immune-compromised status (such as known human immunodeficiency virus infection)
- Have a history of malignancy, excluding basal cell carcinoma of the skin
- Have an active intercurrent infection
- Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
- Have symptoms of a clinically significant illness that may influence the outcome of the study
- Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States5 sites
Metrolina Medical Research
Charlotte, North Carolina, 28209
Premier Medical Group, P.C.
Clarksville, Tennessee, 37040
East Tennessee Medical Research
Johnson City, Tennessee, 37604
New Hanover Medical Research
Wilmington, North Carolina, 28401
Piedmont Medical Research, LLC
Winston-Salem, North Carolina, 27103
Switzerland4 sites
University Hospital
Basel, CH-4031
Inselspital
Bern, 3010
Kantonsspital
Sankt Gallen, CH-9007
University Hospital
Zurich, CH-8091
United Kingdom3 sites
Synexus Midlands
Birmingham, Midlands, B15 2SQ
Synexus Wales
Cardiff, CF14 5GJ
Synexus Scotland
Clydebank, Strathclyde, G81 2DR
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Phase II, Multi-Centre, Study of the Efficacy and Safety of CT 327, a Topical Cream Formulation of Pegylated K252a, When Administered Twice Daily for Eight Weeks to Patients With Mild to Moderate Psoriasis Vulgaris
This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.
- Conditions
- Psoriasis
- Being tested
- placebo, CT 327
- Keywords
- Mild to moderate psoriasis vulgaris
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
1.0 g (w/w) placebo cream applied to both target lesions twice daily
CT 327Drug
1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo only | Placebo comparator | Subjects will apply placebo cream to both target lesions Receives: Drug: placebo |
| Active plus placebo | Active comparator | Subjects will apply CT 327 to one target lesion and placebo to the other target lesion Receives: Drug: CT 327 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8
Measured: 8 weeks
Secondary outcomes (1)
To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creabilis SA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995969
- Sponsor's protocol ID
- CT 327 PV 01-09
- Status last verified
- Feb 2011
- First submitted
- 15 Oct 2009
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Phase II, Multi-Centre, Study of the Efficacy and Safety of CT 327, a Topical Cream Formulation of Pegylated K252a, When Administered Twice Daily for Eight Weeks to Patients With Mild to Moderate Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT00995969
- Acronym / sponsor ID
- CT 327 PV 01-09
- Conditions
- Psoriasis
- Keywords
- Mild to moderate psoriasis vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Creabilis SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Oct 2009 (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.
This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo only | Placebo comparator | Drug: placeboSubjects will apply placebo cream to both target lesions |
| Active plus placebo | Active comparator | Drug: CT 327Subjects will apply CT 327 to one target lesion and placebo to the other target lesion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 and < 71 years of age
- Able to give informed consent
- Diagnosis of mild (affecting < 3% BSA) to moderate (affecting < 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each
Key exclusion criteria (18 listed)
- If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
- If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
- Allergy to test drug or excipients
- Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
- Received treatment with systemic or locally acting medications which might counter or influence the study aim
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 |
|---|---|---|
| placebo1.0 g (w/w) placebo cream applied to both target lesions twice daily | Drug | Placebo only |
| CT 3271.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily | Drug | Active plus placebo |
Primary outcome
Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8
Time frame: 8 weeks
1 secondary outcome
To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8
Time frame: 8 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 10 Feb 2011.
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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.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT 327 in people with Psoriasis, run by Creabilis SA at 12 sites in 3 countries.
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 3 inclusion and 18 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 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Switzerland, United Kingdom. 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 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?
Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8 (time frame: 8 weeks). 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 10 Feb 2011.