Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

NCT02387853 | Completed Phase 2 Results

• 1 other identifier: LP0053-1108
• Study Type: interventional
• Target: 117
• Locations: 4 countries
• Sites: 9

Brief Summary

An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Adverse Events (AEs)

  Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.

  From Week -1 to Week 8

• Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4

  Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.

  30 minutes after ACTH-challenge at Week 4

• Change in Albumin-corrected Serum Calcium From Baseline to Week 4

  Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.

  From baseline to Week 4

• Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4

  Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.

  From baseline to Week 4

• Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4

  Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.

  From baseline to Week 4

Secondary Outcomes (8)

• Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4

  30 and 60 minutes after ACTH-challenge at Week 4

• Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4

  From baseline to Week 4

• Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body

  Week 4

• Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp

  Week 4

• Percentage Change in PASI From Baseline to Week 4

  From baseline to Week 4

Study Arms (1)

LEO 90100

EXPERIMENTAL

Drug: LEO 90100

Interventions

LEO 90100 DRUG

LEO 90100

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA.
• Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area.
• A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
• PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
• PGA score of at least mild on scalp at SV1, SV2 and V1.
• A serum albumin-corrected calcium below the upper reference limit at SV2.
• Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA.
• Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area.
• PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1.
• PGA score of at least moderate on scalp at SV1, SV2 and V1.
• Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).

You may not qualify if:

• A history of hypersensitivity to any component of LEO 90100.
• Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
• etanercept - within 4 weeks prior to V1
• adalimumab, infliximab - within 2 months prior to V1
• ustekinumab - within 4 months prior to V1
• experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1
• Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
• PUVA therapy within 4 weeks prior to V1.
• UVB therapy within 2 weeks prior to V1 or during the trial.
• A history of serious allergy, allergic asthma or serious allergic skin rash.
• Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
• Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
• Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (9)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Redwood Family Dermatology

Santa Rosa, California, 95403-2805, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059-3526, United States

Location

Greenwich Village Dermatology

New York, New York, 10012, United States

Location

Skin Speciality Dermatology

New York, New York, 10155, United States

Location

Dermatology Treatment and Research Center PA

Dallas, Texas, 75230-5808, United States

Location

UMC St Radboud

Nijmegen, 6525, Netherlands

Location

MULTIKLINIKA SALUTE Sp zo.o.

Katowice, 40-123, Poland

Location

Spitalul Clinic de Boli Infectioase si Tropicale

Bucharest, 030303, Romania

Location

Results Point of Contact

• Title: Clinical Disclosure Specialist
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 44945888

Study Officials

• M Seyger, MD

  UMC St Radboud

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 13, 2015
• Study Start: March 1, 2016
• Primary Completion: March 28, 2018
• Study Completion: March 28, 2018
• Last Updated: March 10, 2025
• Results First Posted: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); NL (1); PL (1); US (6)