Trial Twice Daily Application of LEO 124249 Ointment 30 mg/g in Treatment of Mild to Moderate Inverse Psoriasis

NCT02695940 | Completed Phase 2

• 1 other identifier: LP0133-1182
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inverse Psoriasis

Outcome Measures

Primary Outcomes (1)

• The total sign score (TSS) at Week 6 (Visit 6)

  after 6 weeks of treatment

Secondary Outcomes (14)

• For PGA, the number of subjects reaching controlled disease at Visit 6 (Week 6)

  after 6 weeks of treatment

• Score for clinical sign redness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)

  after 6 weeks of treatment

• Score for clinical sign thickness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)

  after 6 weeks of treatment

• Score for clinical sign scaliness for inverse psoriasis: (score 0 to 4) at Visit 6 (Week 6)

  after 6 weeks of treatment

• Size of treatment area of inverse psoriasis at Visit 6 (Week 6)

  after 6 weeks of treatment

Study Arms (2)

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

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

Other: LEO 124249 ointment vehicle

Interventions

LEO 124249 ointment 30 mg/g DRUG

LEO 124249 ointment 30 mg/g

LEO 124249 ointment vehicle OTHER

LEO 124249 ointment vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Johannes Niesmann

Bochum, 44803, Germany

Location

Related Links

• LEO Pharma Clinical Trials

Study Officials

• Thomas Luger, MD

  Universitätsklinikum Münster, Klinik fur Hautkrankheiten

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 2, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 24, 2025

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)