Phase 2
N=107
An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02038569 ↗Enrolled (actual)
107
Serious AEs
0.9%
Results posted
Nov 2018
Primary outcome: Primary: Adverse Drug Reactions (ADRs) — 2; 1; 1; 1 Number of adverse drug reactions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEO 80185 gel (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Drug Reactions (ADRs) |
2; 1; 1; 1; 1; 1 | — |
| PRIMARY Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 |
4; 27 | — |
| PRIMARY Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8 |
2; 27; 2 | — |
| PRIMARY Change in Albumin-corrected Serum Calcium From Baseline to Week 4 |
-0.012 | — |
| PRIMARY Change in Albumin-corrected Serum Calcium From Baseline to Week 8 |
-0.008 | — |
| PRIMARY Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment |
-0.003 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 |
-0.493 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 |
0.040 | — |
| PRIMARY Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment |
0.069 | — |
| SECONDARY Adverse Events (AEs) |
6; 2; 1; 1; 1; 1 | — |
| SECONDARY Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4 |
0; 31 | — |
| SECONDARY Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8 |
0; 29; 2 | — |
| SECONDARY Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 |
-0.098 | — |
| SECONDARY Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 |
0.219 | — |
| SECONDARY Change in Serum Alkaline Phosphatase From Baseline to Week 4 |
-0.4 | — |
| SECONDARY Change in Serum Alkaline Phosphatase From Baseline to Week 8 |
-6.8 | — |
| SECONDARY Pharmacokinetic Evaluation AUC(0-t) |
NA; 325 | — |
| SECONDARY Pharmacokinetic Evaluation AUC(0-infinity) |
NA; 325 | — |
| SECONDARY Pharmacokinetic Evaluation C(Max) |
104; 126 | — |
| SECONDARY Pharmacokinetic Evaluation T(Max) |
NA; NA | — |
| SECONDARY Pharmacokinetic Evaluation T(½) |
NA; NA | — |
| SECONDARY Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment |
62; 45 | — |
| SECONDARY Percentage Change in PASI From Baseline to End of Treatment |
-78.7 | — |
| SECONDARY Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment |
67; 40 | — |
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.
Eligibility Criteria
Inclusion Criteria (all subjects):
- 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
Inclusion Criteria (for subjects performing HPA axis assessments):
- 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.
Inclusion Criteria (for subjects not performing HPA axis assessments):
- 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.
Exclusion Criteria (all subjects):
- 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.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
- Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
- Current participation in any other interventional clinical trial.
- Previously enrolled in this trial.
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not y
Data sourced from ClinicalTrials.gov (NCT02038569). 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.