Back to resultsTopical SGX302 for Mild-to-Moderate Psoriasis
Primary Purpose
Psoriasis, Plaque Psoriasis, Psoriasis Vulgaris
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hypericin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Hypericin
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.
Sites / Locations
- Therapeutics Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SGX302 (Ointment with 0.25 % Hypericin)
Placebo (Ointment without Hypericin)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05442190
Brief Title
Topical SGX302 for Mild-to-Moderate Psoriasis
Official Title
Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soligenix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Plaque Psoriasis, Psoriasis Vulgaris
Keywords
Hypericin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGX302 (Ointment with 0.25 % Hypericin)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Ointment without Hypericin)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hypericin
Other Intervention Name(s)
SGX302
Intervention Description
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin.
Primary Outcome Measure Information:
Title
Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale
Description
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
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index
Description
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)).
Time Frame
18 weeks
Title
Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index
Description
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.
Time Frame
18 weeks
Title
Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index
Description
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.
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Pullion, DO
Phone
609-538-8200
Email
cpullion@soligenix.com
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noe Guerrero
Phone
858-571-6800
Ext
141
First Name & Middle Initial & Last Name & Degree
Neal Bhatia, MD
12. IPD Sharing Statement
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Topical SGX302 for Mild-to-Moderate Psoriasis
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