Inverse PsoriasisPhase 2NCT02695940
Trial Twice Daily Application of LEO 124249 Ointment 30 mg/g in Treatment of Mild to Moderate Inverse Psoriasis
A Phase 2 study testing LEO 124249 ointment 30 mg/g in people with Inverse Psoriasis, run by LEO Pharma at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inverse Psoriasis
- What is being tested?
- LEO 124249 ointment 30 mg/g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Sep 2016
- 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
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inverse Psoriasis
- Being tested
- LEO 124249 ointment 30 mg/g, LEO 124249 ointment vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 124249 ointment 30 mg/gDrug
LEO 124249 ointment vehicleOther
| Study group | Role | What they receive |
|---|---|---|
| LEO 124249 ointment 30 mg/g | Active comparator | Drug LEO 124249 ointment 30 mg/g twice daily application for 6 weeks, maximum of 1.44 g ointment per day Receives: Drug: LEO 124249 ointment 30 mg/g |
| LEO 124249 ointment vehicle | Placebo comparator | LEO 124249 ointment vehicle twice daily application for 6 weeks, maximum of 1.44 g ointment per day Receives: Other: LEO 124249 ointment vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total sign score (TSS) at Week 6 (Visit 6)
Measured: after 6 weeks of treatment
Secondary outcomes (14)
For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
Score for clinical sign thickness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
Size of treatment area of inverse psoriasis at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
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))
Measured: after 6 weeks of treatment
Subjects overall assessment of cosmetic acceptability at Visit 6 (Week 6)
Measured: after 6 weeks of treatment
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
Measured: after 6 weeks of treatment
Adverse Events
Measured: after 6 weeks of treatment
Abnormal and clinically significant findings in blood pressure, heart rate, body temperature will be listed
Measured: after 6 weeks of treatment
Abnormal and clinically significant laboratory parameters will be listed
Measured: after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inverse 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Luger, MD, Principal investigator, Universitätsklinikum Münster, Klinik fur Hautkrankheiten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695940
- Sponsor's protocol ID
- LP0133-1182
- Status last verified
- May 2017
- First submitted
- 18 Feb 2016
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02695940
- Acronym / sponsor ID
- LP0133-1182
- Conditions
- Inverse Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Mar 2016 (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 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.
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 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 |
|---|---|---|
| LEO 124249 ointment 30 mg/g | Active comparator | Drug: LEO 124249 ointment 30 mg/gDrug LEO 124249 ointment 30 mg/g twice daily application for 6 weeks, maximum of 1.44 g ointment per day |
| LEO 124249 ointment vehicle | Placebo comparator | Other: LEO 124249 ointment vehicleLEO 124249 ointment vehicle twice daily application for 6 weeks, maximum of 1.44 g ointment per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| LEO 124249 ointment 30 mg/g | Drug | LEO 124249 ointment 30 mg/g |
| LEO 124249 ointment vehicle | Other | LEO 124249 ointment vehicle |
Primary outcome
The total sign score (TSS) at Week 6 (Visit 6)
Time frame: after 6 weeks of treatment
14 secondary outcomes
For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Score for clinical sign thickness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Size of treatment area of inverse psoriasis at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
For PaGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Dermatology Life Quality Index (DLQI) questionnaire at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
Treatment satisfaction questionnaire for medication (TSQM II) at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
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
Subjects overall assessment of cosmetic acceptability at Visit 6 (Week 6)
Time frame: after 6 weeks of treatment
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
Adverse Events
Time frame: after 6 weeks of treatment
Abnormal and clinically significant findings in blood pressure, heart rate, body temperature will be listed
Time frame: after 6 weeks of treatment
Abnormal and clinically significant laboratory parameters will be listed
Time frame: after 6 weeks of treatment
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 24 Feb 2025.
- LEO Pharma Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Inverse Psoriasis
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Psoriasis, Psoriasis Genital
Not yet recruitingPhase 2
EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis
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.
Thomas Luger, MD principal investigator
Universitätsklinikum Münster, Klinik fur Hautkrankheiten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 124249 ointment 30 mg/g in people with Inverse Psoriasis, run by LEO Pharma at 1 site in Germany.
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 13 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The total sign score (TSS) at Week 6 (Visit 6) (time frame: after 6 weeks of treatment). 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 24 Feb 2025.