Topical SGX302 for Mild-to-Moderate Psoriasis

Study Overview
=================
Brief Summary
-----------------
To evaluate SGX302 (topical hypericin ointment) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.

Official Title
-----------------
Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis

Conditions
-----------------
Psoriasis, Plaque Psoriasis, Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Hypericin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application. Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs). Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%. Exclusion Criteria: Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study. Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study. Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study. Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This is a 2 part study. All protocol procedures, timing for schedule of events and assessments are identical for Parts A and B. In Part A, 5-10 patients will be assigned open-label SGX302. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, approximately 32 patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to a placebo ointment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGX302 (Ointment with 0.25 % Hypericin)<br>SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. | Drug: Hypericin<br>* SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment.<br>* Other names: SGX302;|
| Placebo Comparator: Placebo (Ointment without Hypericin)<br>Placebo ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. | Drug: Placebo<br>* Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale | The percentage of patients in each treatment group that achieve a 0 or 1 score (Clear or Almost Clear) evaluation using the 5-point Investigator's Global Assessment (IGA) scale. The 5-point IGA scale: Score 0: Clear - No signs of psoriasis; post-inflammatory hyperpigmentation may be present Score 1: Almost Clear - No thickening; normal to pink coloration; no to minimal focal scaling Score 2: Mild - Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling Score 3: Moderate - Clear distinguishable to moderate thickening; dull to bright red; moderate scaling Score 4: Severe - Severe thickening with hard edges; bright to deep red coloration; severe/coarse scaling covering almost all lesions | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index | The percentage of patients in each treatment group that achieve a ≥75% improvement in Psoriasis Area and Severity Index (PASI 75). PASI is a combined assessment of lesion severity and affected area into a single score. The body is divided into 4 areas for scoring: head, arms, trunk and legs. Each area is scored by itself and scores are combined for a final PASI. For each area, scores of erythema, thickness and scale are scored on a scale of 0 (clear) to 4 (maximum). For each area, percent of skin involved is estimated: 0 = 0%, 1= 0 to ≤10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to ≤90%, 6 = 90 to100%. Final PASI = (sum of severity parameters for each area)*(area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)). | 18 weeks | 
| Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index | The percentage of patients in each treatment group that achieve a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90). The calculation of PASI was previously described. | 18 weeks | 
| Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index | The percentage of patients in each treatment group that achieve a 100% improvement in Psoriasis Area and Severity Index (PASI 100). The calculation of PASI was previously described. | 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypericin