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

Phase 2

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: LEO 80185 gel

Registration Number: NCT02038569

Lead Sponsor: LEO Pharma

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.

Detailed Description: A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel containing calcipotriol 50 mcg/g plus betamethasone 0.5mg/g (as dipropionate) in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEO 80185 gel	LEO 80185 gel	-

Primary Outcome Measures

Name	Time	Method
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 Week 8
Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment	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.
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 4
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	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment	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.
Adverse Drug Reactions (ADRs)	8 weeks	Number of Adverse Drug Reactions (ADRs)
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 Week 8
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	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at 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 4

Secondary Outcome Measures

Name	Time	Method
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8	From baseline to Week 8	Change in urinary calcium:creatinine ratio from baseline to Week 8
Pharmacokinetic Evaluation C(Max)	Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP	C(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore pharmacokinetic profiles could not be calculated. Presented C(max) values for betamethasone dipropionate and betamethasone 17-propionate are the the single highest concentrations measured in any sample at any time. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Percentage Change in PASI From Baseline to End of Treatment	From baseline to end of treatment	Percentage change in Psoriasis area and severity index (PASI) score from baseline to end of treatment, defined as the last value recorded up to and including Week 8. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
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	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 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	Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 8
Change in Serum Alkaline Phosphatase From Baseline to Week 4	From baseline to Week 4	Change in serum alkaline phosphatase from baseline to Week 4
Adverse Events (AEs)	8 weeks	Number of Adverse Events (AEs)
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 4
Change in Serum Alkaline Phosphatase From Baseline to Week 8	From baseline to Week 8	Change in serum alkaline phosphatase from baseline to Week 8
Pharmacokinetic Evaluation AUC(0-t)	Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP	AUC(0-t) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-t) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-t). The mean value of AUC(0-t) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Pharmacokinetic Evaluation AUC(0-infinity)	Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP	AUC(0-infinity) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-infinity) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-infinity). The mean value of AUC(0-infinity) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080. The terms AUC(0-infinity) and AUC(all) are interchangeable, AUC(0-infinity) was used in the protocol whereas AUC(all) was used in the report. AUC(0-infinity) has been used here to be consistent with the protocol.
Pharmacokinetic Evaluation T(½)	Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP	T(½) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore it was not possible to calculate T(½) for betamethasone dipropionate or betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment	End of treatment	Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the investigator's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.
Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment	End of treatment	Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the patient's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.
Pharmacokinetic Evaluation T(Max)	Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP	T(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects. Therefore it was not possible to calculate T(max) for betamethasone dipropionate and betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.

Trial Locations

Locations (35): Rady's Children Hospital
🇺🇸
San Diego, California, United States
Clinical Research Center, Morsani Center for Advanced Healthcare
🇺🇸
Tampa, Florida, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Skin Specialists, PC
🇺🇸
Omaha, Nebraska, United States
St. Luke's Roosevelt Hospital
🇺🇸
Forest Hills, New York, United States
Clinical Partners
🇺🇸
Johnston, Rhode Island, United States
Dermatology and Laser Center of Charleston, PA
🇺🇸
Charleston, South Carolina, United States
Clinical Trials of Texas, Inc.
🇺🇸
San Antonio, Texas, United States
Winnipeg Clinic
🇨🇦
Winnipeg, Manitoba, Canada
Adult, Pediatric and Laser Derma
🇨🇦
St-John's, Newfoundland and Labrador, Canada
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Rady's Children Hospital
🇺🇸San Diego, California, United States