Plaque PsoriasisPhase 2NCT00746434
A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis
A Phase 2 study testing Roflumilast cream in people with Plaque Psoriasis, run by AstraZeneca.
Trial summary
The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of plaque psoriasis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Roflumilast cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (who is able to read, to write and to fully understand English language) has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patient is suffering from mild to moderate plaque psoriasis
- Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 3% to a maximum of 10% BSA affected by mild to moderate plaque psoriasis proven by a dermatologist.
- Patient must have a minimum of 1 and a maximum of 3 in severity score of psoriasis
- Patient must have at least one target lesion of at least 1% BSA.
- Patient must be willing to wash out from current active therapy for at least 14 days prior to Day 1.
- Women of childbearing potential must have a negative pregnancy test at the Screening and Baseline Visits and agree to use a highly effective method of birth control. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
Who cannot join
- Patient has spontaneously improving or rapidly deteriorating plaque psoriasis within at least the past 3 month.
- Patients who have a known history of psoriasis unresponsive to topical treatments.
- Patient has a physical condition (e.g., atopic dermatitis, contact dermatitis, tinea corporis) which, in the Investigator's opinion, might impair evaluation of plaque psoriasis or which exposes the patient to an unacceptable risk by trial participation.
- Clinically relevant abnormal laboratory values and vital signs suggesting an unknown underlying disease and requiring further clinical evaluation (as assessed by the Investigator).
- Patient is pregnant, nursing or planning a pregnancy during the trial period.
- Patient is currently enrolled in an investigational drug or device trial.
Show all 10Show fewer
- Patient has received an investigational drug or an investigational device within 30 days prior to trial start.
- Patient has a history of allergic reactions to roflumilast or any inactive ingredients of the trial medication.
- Patient has positive results in any of the virology tests of acute or chronic infectious HIV and hepatitis virus infections.
- Abuse of alcohol or drugs
About this study
The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of plaque psoriasis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 3-10 % of the body surface area (BSA) should be covered with a mild to moderate form of plaque psoriasis. In a 4-week treatment period 76 mg cream is applied two times daily on up to 2% of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows. As roflumilast is a potent anti-inflammatory substance, a positive effect on this form of dermal disease is anticipated.
- Conditions
- Plaque Psoriasis
- Being tested
- Roflumilast cream, Placebo cream
- Keywords
- Mild plaque psoriasis,, Moderate plaque psoriasis,, 0.5% Roflumilast cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast creamDrug
Roflumilast cream 0.5%
Placebo creamDrug
Placebo cream
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Roflumilast cream 0.5% Receives: Drug: Roflumilast cream |
| 2 | Placebo comparator | Placebo cream Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical signs and symptoms score
Measured: 28 days
Secondary outcomes (1)
Improvement of plaque psoriasis severity score, improvement of patient judged pruritus severity, change in dermal questionnaire, safety and efficacy
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 posted4 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: Study withdrawn due to business decisions. No subjects were treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fougera Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746434
- Sponsor's protocol ID
- RO-2351-002-EM
- Status last verified
- Oct 2016
- First submitted
- 3 Sep 2008
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00746434
- Acronym / sponsor ID
- RO-2351-002-EM
- Conditions
- Plaque Psoriasis
- Keywords
- Mild plaque psoriasis,, Moderate plaque psoriasis,, 0.5% Roflumilast cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to business decisions. No subjects were treated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fougera Pharmaceuticals Inc.
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 4 Sep 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 aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of plaque psoriasis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 3-10 % of the body surface area (BSA) should be covered with a mild to moderate form of plaque psoriasis. In a 4-week treatment period 76 mg cream is applied two times daily on up to 2% of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows. As roflumilast is a potent anti-inflammatory substance, a positive effect on this form of dermal disease is anticipated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Roflumilast creamRoflumilast cream 0.5% |
| 2 | Placebo comparator | Drug: Placebo creamPlacebo cream |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient (who is able to read, to write and to fully understand English language) has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patient is suffering from mild to moderate plaque psoriasis
- Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 3% to a maximum of 10% BSA affected by mild to moderate plaque psoriasis proven by a dermatologist.
- Patient must have a minimum of 1 and a maximum of 3 in severity score of psoriasis
- Patient must have at least one target lesion of at least 1% BSA.
Key exclusion criteria (10 listed)
- Patient has spontaneously improving or rapidly deteriorating plaque psoriasis within at least the past 3 month.
- Patients who have a known history of psoriasis unresponsive to topical treatments.
- Patient has a physical condition (e.g., atopic dermatitis, contact dermatitis, tinea corporis) which, in the Investigator's opinion, might impair evaluation of plaque psoriasis or which exposes the patient to an unacceptable risk by trial participation.
- Clinically relevant abnormal laboratory values and vital signs suggesting an unknown underlying disease and requiring further clinical evaluation (as assessed by the Investigator).
- Patient is pregnant, nursing or planning a pregnancy during the trial period.
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 |
|---|---|---|
| Roflumilast creamRoflumilast cream 0.5% | Drug | 1 |
| Placebo creamPlacebo cream | Drug | 2 |
Primary outcome
Improvement of clinical signs and symptoms score
Time frame: 28 days
1 secondary outcome
Improvement of plaque psoriasis severity score, improvement of patient judged pruritus severity, change in dermal questionnaire, safety and efficacy
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
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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.
AstraZeneca AstraZeneca study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast cream in people with Plaque Psoriasis, run by AstraZeneca.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Improvement of clinical signs and symptoms score (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 5 Dec 2016.