Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis

Study Overview
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Brief Summary
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This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.

Official Title
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A Multicenter, Randomized, Vehicle-controlled, Efficacy and Safety Study of CD2027 3µg/g Oily Spray Applied Twice Daily for 8 Weeks in Subjects With Plaque-type Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: CD 2027
* Drug: Calcitriol Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening Participant presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4 Exclusion Criteria: Other type of psoriasis (other than plaque) Significant abnormal lab findings Hypercalcemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol 3 mcg/g Spray<br> | Drug: CD 2027<br>* Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.<br>* Other names: Calcitriol;|
| Placebo Comparator: Calcitriol Vehicle<br> | Drug: Calcitriol Vehicle<br>* Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Success Rate 1 (SR1) at Week 8 | Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF). | Week 8 | 
| Percentage of Participants With Success Rate 2 (SR2) at Week 8 | Success Rate 2 was defined as percentage of participants who achieved clear or almost clear on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF). | Week 8 | 
| Change From Baseline in Dermatologic Sum Score (DSS) at Week 8 | DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition. | Baseline, Week 8 | 
| Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation | Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation). | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | up to Week 8 | 
| Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score | Local tolerability skin assessments were performed by the investigator and based on 5-point scale which ranges from 0 to 4. 0 = none (no evidence of local intolerance); 1=mild (minimal erythema and/or edema, slight glazed appearance); 2 = moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology); 3 = severe (erythema, edema glazing with fissures, few vesicles or papules) and 4 = very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions). Higher grades indicated worsening of condition. Percentage of participants with increase in score by Week 8 from baseline has been presented here, where the row titles indicate participant's new scores by Week 8. | up to Week 8 | 
| Change From Baseline in Calcitriol Plasma Levels | Change from baseline in calcitriol plasma levels were reported. | Baseline, Week 8 | 
| Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin | Change from baseline in serum calcium homeostasis parameter (Albumin) were reported. | Baseline, Week 8 | 
| Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium | Change from baseline in serum calcium homeostasis parameter (Albumin-adjusted calcium) were reported. | Baseline, Week 8 | 
| Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium | Change from baseline in serum calcium homeostasis parameter (Calcium) were reported. | Baseline, Week 8 | 
| Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus | Change from baseline in serum calcium homeostasis parameter (Phosphorus) were reported. | Baseline, Week 8 | 
| Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact | Change from baseline in serum calcium homeostasis parameter (PTH intact) were reported. | Baseline, Week 8 | 
| Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) | Change from baseline in Blood Chemistry: Alkaline Phosphatase, AST and ALT were reported. | Baseline, Week 8 | 
| Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine | Change from baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, BUN and Creatinine were reported. | Baseline, Week 8 | 
| Change From Baseline in Vital Sign Parameter: Heart Rate | Change from baseline in vital sign parameter: heart rate was reported. | Baseline, Week 8 | 
| Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure | Change from baseline in vital sign parameter: Systolic Blood Pressure and Diastolic Blood Pressure was reported. | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, spray, calcitriol