An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects

NCT02038569 | Completed Phase 2 Results

• 1 other identifier: LP0076-1017
• Study Type: interventional
• Target: 125
• Locations: 7 countries
• Sites: 35

Brief Summary

An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (9)

• Adverse Drug Reactions (ADRs)

  Number of Adverse Drug Reactions (ADRs)

  8 weeks

• 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

  30 minutes after ACTH-challenge at Week 4

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8

  Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8

  30 minutes after ACTH-challenge at Week 8

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

  Change in albumin-corrected serum calcium from baseline to Week 4

  From baseline to Week 4

• Change in Albumin-corrected Serum Calcium From Baseline to Week 8

  Change in albumin-corrected serum calcium from baseline to Week 8

  From baseline to Week 8

• Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment

  Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.

  From baseline to end of treatment

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

  Change in 24-hour urinary calcium excretion from baseline to Week 4

  From baseline to Week 4

• Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8

  Change in 24-hour urinary calcium excretion from baseline to Week 8

  From baseline to Week 8

• Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment

  Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.

  From baseline to end of treatment

Secondary Outcomes (15)

• Adverse Events (AEs)

  8 weeks

• Subjects With Serum Cortisol Concentration of ≤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

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8

  30 and 60 minutes after ACTH-challenge at Week 8

• Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4

  From baseline to Week 4

• Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8

  From baseline to Week 8

Study Arms (1)

LEO 80185 gel

EXPERIMENTAL

Drug: LEO 80185 gel

Interventions

LEO 80185 gel DRUG

LEO 80185 gel

Eligibility Criteria

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

You may qualify if:

• Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs)
• At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis which is:
• of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions of the face and sensitive areas. Sensitive areas include armpits, groin, under the breasts and in other skin folds around the genitals and buttocks), and
• of at least moderate severity according to the investigator's global assessment of disease severity on the body.
• A serum albumin-corrected calcium level below the upper reference limit at SV2
• At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
• more than or equal to 20% of the scalp area, and
• of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.
• Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge.
• At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
• more than or equal to 10% of the scalp area, and
• of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.

You may not qualify if:

• 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 Visit 1 and during the trial:
• etanercept - within 4 weeks prior to Visit 1
• adalimumab, infliximab - within 2 months prior to Visit 1
• ustekinumab - within 4 months prior to Visit 1
• experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
• Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
• UVB therapy within 2 weeks prior to Visit 1 or during the trial.
• Any topical treatment on the scalp and body (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
• Systemic calcium, vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.
• Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the trial.
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
• Subjects with any of the following conditions present on the treatment areas on scalp and/or body: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
• Other inflammatory skin diseases that may confound the evaluation of scalp and/or body psoriasis.
• Planned excessive exposure to sun during the trial that may affect scalp and/or body psoriasis.
• Known or suspected severe renal insufficiency or severe hepatic disorders.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (35)

Rady's Children Hospital

San Diego, California, 92132, United States

Location

Clinical Research Center, Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

St. Luke's Roosevelt Hospital

Forest Hills, New York, 10025, United States

Location

Clinical Partners

Johnston, Rhode Island, 12095, United States

Location

Dermatology and Laser Center of Charleston, PA

Charleston, South Carolina, 29407, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Adult, Pediatric and Laser Derma

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 1Z2, Canada

Location

CHU de Nice

Nice, Alpe-Maritimes, 06202, France

Location

Cabinet Medical

Martigues, Bouches-du-Rhône, 13500, France

Location

CHI de Cornouaille

Quimper, Finistère, 29107, France

Location

Charite Berlin

Berlin, 10117, Germany

Location

Uniklinik Bonn

Bonn, 53127, Germany

Location

Uniklinik Frankfurt

Frankfurt am Main, 60590, Germany

Location

Katholisches Kinderkrankenhaus

Hamburg, 22149, Germany

Location

Endo - Med. Centrum Medyczne Clinic

Karczew, 05-480, Poland

Location

NZOZ Med.-Laser Clinic

Lublin, 20-146, Poland

Location

Specjalistyczny Ofrodek Leczniczo Clinic

Ostróda, 14-100, Poland

Location

Medycyna Kliniczna Clinic

Warsaw, 00-660, Poland

Location

Derm Medica Sp.zo.o. Clinic

Wroclaw, 51-318, Poland

Location

Policlinica de Diagnostic Rapid S.A. Clinic

Brasov, 500152, Romania

Location

Spitalul Clinic "Colentina"

Bucharest, 20125, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, 400006, Romania

Location

Cabinet Medical Individual Tatu G. Alin Laurentiu

Galati, 800101, Romania

Location

Iasiprest SRL Dermato-Venerology

Iași, 700381, Romania

Location

Spitalul Clinic Judetean Mures

Târgu Mureş, 800373, Romania

Location

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, 300077, Romania

Location

Manchester Royal Infirmary

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Monklands Hospital

Airdrie, Lanarkshire, ML6 OJ5, United Kingdom

Location

Whipps Cross University Hospital

Leytonstone, London, E11 1NR, United Kingdom

Location

St. Woolos Hospital

Stow Hill, Newport, Monmouthshire, NP20 4SZ, United Kingdom

Location

Results Point of Contact

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

disclosure@leo-pharma.com

+45 44945888

Study Officials

• Lawrence Eichenfield, MD

  Rady Chilidren's Hospital

  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: January 13, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 13, 2018
• Last Updated: March 10, 2025
• Results First Posted: November 6, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); DE (4); GB (4); FR (3); PL (5); RO (7); CA (4)