- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695940
Trial Twice Daily Application of LEO 124249 Ointment 30 mg/g in Treatment of Mild to Moderate Inverse Psoriasis
November 14, 2018 updated by: LEO Pharma
A Phase 2a, Proof of Concept Trial, Testing Twice Daily Application of LEO 124249 Ointment 30 mg/g in the Treatment of Mild to Moderate Inverse Psoriasis
This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g in the treatment of mild to moderate inverse psoriasis.
Patients will be treated for 6 weeks, and the efficacy and safety will be compared with the treatment of LEO 124249 ointment vehicle.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Single country, Multi-center, prospective, randomised, double-blind, 2 arms parallel-group, vehicle-controlled, 6 weeks, phase 2a trial in subjects with mild to moderate inverse psoriasis.
LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle treatments will be compared with regards to efficacy and safety.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bochum, Germany, 44803
- Johannes Niesmann
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated informed consent prior to any trial specific procedures
- Male or female subjects between 18 to 75 years
- A diagnosis of stable mild to moderate inverse psoriasis (i.e. axillae, the infra- and intermammary, genital, scrotum, abdominal and retroauricular folds; the intergluteal cleft and perianal skin, in addition to neck or other skin folds). Mild to moderate is defined as having at least score 1 for each individual sign thickness and redness, and total TSS score of at least 5.
- The total treatment area can be up to 4% BSA (720 cm2).
- Subjects must have a history of psoriasis, or have psoriasis, or present with characteristic psoriasis leasons elsewhere on the body (including the scalp) at Visit 1 (Screening)
- Stable inverse psoriasis based on TSS evaluated at Visit 1 (Screening) and at Visit 2 (Start of treatment), which must not differ more than 1 point in any single clinical sign score (redness, scaling and thickness)
- Except for inverse psoriasis, overall good health including well controlled diseases (e.g. hypertension, diabetes, and thyroid disease) as determined by medical history, physical examination, electrocardiogram (ECG), vital signs (blood pressure, heart rate and body temperature) and clinical laboratory evaluation
Exclusion Criteria:
- Female subjects who are breastfeeding or pregnant
- Severe chronic inverse psoriasis, or psoriasis on the body (>30% of BSA)
- Current diagnosis of acute guttate, erythrodermic, exfoliative or pustular psoriasis
- Signs of viral (e.g. herpes or varicella) lesions of the skin, or signs of clinically active fungal or bacterial infection in any of the inverse psoriasis areas, as judged by the investigator
- Use of biological therapies (marketed/not marketed) with a possible effect on inverse psoriasis within 4 weeks (etanercept), 8 weeks (adalimumab, alefacept, infliximab), 16 weeks (ustekinumab, secukinumab) or 4 weeks/5 half-lives (whichever is longer) for experimental biological products prior to Visit 2 (Start of treatment)
- Use of systemic treatments (marketed/non-marketed), other than biologics, with a potential effect on inverse psoriasis (e.g., corticosteroids, retinoids, dimethylfumarate, cyclosporine, azathioprine methotrexate, immunosuppressants) within 6 weeks prior to Visit 2 (Start of treatment) (inhaled or intranasal steroids corresponding of up to 1 mg prednisone for asthma or rhinitis may be used)
- Use of very potent topical corticosteroids (WHO group IV) for the treatment of psoriasis on the body and/or scalp within 4 weeks prior to Visit 2 (Start of treatment)
- Use of topical medication for the treatment of inverse psoriasis: WHO group I-III corticosteroids, retinoids, vitamin D analogues, immunomodulators (e.g. macrolides, calcineurin), anthracen derivatives, tar, or salicylic acid within 2 weeks prior to Visit 2 (Start of treatment)
- Exposure to phototherapy (PUVA, UVA, UVB, Grenz Ray therapy) within 4 weeks prior to Visit 2 (Start of treatment)
- Subjects with a positive HBV score antibody, HBsAg, anti-HCV or anti-HIV test at Visit 1 (Screening)
- Subjects with history of an immunocompromising disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome)
- Any current dermatological disorder (e.g. serborrhic dermatitis, contact dermatitis, cutaneous mycosis) which may confound the evaluation of inverse psoriasis
- Known malignancy (other than cervical carcinoma in situ, basal cell or squamous cell carcinoma) within 5 years before Visit 1 (Screening)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: LEO 124249 ointment 30 mg/g
Drug LEO 124249 ointment 30 mg/g twice daily application for 6 weeks, maximum of 1.44 g ointment per day
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Placebo Comparator: LEO 124249 ointment vehicle
LEO 124249 ointment vehicle twice daily application for 6 weeks, maximum of 1.44 g ointment per day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total sign score (TSS) at Week 6 (Visit 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Score for clinical sign thickness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Size of treatment area of inverse psoriasis at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Subjects assessment of itching (daily assessment in diary of the first 14 days on treatment (between Visits 2 (Start of treatment) to 4 (Week 2), followed by assessments at the following Visits 4 (Week 2) to 6 (Week 6))
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Subjects overall assessment of cosmetic acceptability at Visit 6 (Week 6)
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Evaluation of population steady state pharmacokinetics of LEO 124249 at Visit 3 (Week 1), by sampling of 1 blood sample to get 1 plasma concentration value per patient after 1 weeks treatment
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Adverse Events
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Abnormal and clinically significant findings in blood pressure, heart rate, body temperature will be listed
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Abnormal and clinically significant laboratory parameters will be listed
Time Frame: after 6 weeks of treatment
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after 6 weeks of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Luger, MD, Universitätsklinikum Münster, Klinik fur Hautkrankheiten
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
February 18, 2016
First Submitted That Met QC Criteria
March 1, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Actual)
November 15, 2018
Last Update Submitted That Met QC Criteria
November 14, 2018
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0133-1182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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