A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis

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 Overview

• Status: Withdrawn
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo cream; Drug: Roflumilast cream

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Roflumilast cream 0.5%	Drug: Roflumilast cream; Roflumilast cream 0.5%
Placebo Comparator: 2; Placebo cream	Drug: Placebo cream; Placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of clinical signs and symptoms score	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement of plaque psoriasis severity score, improvement of patient judged pruritus severity, change in dermal questionnaire, safety and efficacy	28 days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Fougera Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: September 3, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (Estimate): September 4, 2008

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Mild plaque psoriasis,; Moderate plaque psoriasis,; 0.5% Roflumilast cream
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: RO-2351-002-EM