Phase 2
N=106
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02387853 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Subjects With Adverse Events (AEs) — 8; 4; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEO 90100 (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events (AEs) |
8; 4; 1; 1; 1; 1 | — |
| PRIMARY Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 |
3; 30 | — |
| PRIMARY Change in Albumin-corrected Serum Calcium From Baseline to Week 4 |
-0.016 | — |
| PRIMARY Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4 |
-0.335 | — |
| PRIMARY Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4 |
-0.2892 | — |
| SECONDARY Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 |
1; 32 | — |
| SECONDARY Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4 |
0.4620 | — |
| SECONDARY Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body |
74; 29 | — |
| SECONDARY Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp |
78; 25 | — |
| SECONDARY Percentage Change in PASI From Baseline to Week 4 |
-82.05 | — |
| SECONDARY Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 |
86; 17 | — |
| SECONDARY Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 |
84; 19 | — |
| SECONDARY Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 |
-32.5 | — |
Summary
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
Eligibility Criteria
Inclusion Criteria (all subjects)
- 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.
Inclusion Criteria (for subjects performing HPA axis assessment)
- 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).
Exclusion Criteria (all subjects):
- 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.
Exclusion Criteria (for subjects performing HPA axis assessment):
- 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.
Data sourced from ClinicalTrials.gov (NCT02387853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.