Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis
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|ClinicalTrials.gov Identifier: NCT03431974|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Aminopterin oral capsule Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial to Establish the Efficacy and Safety of Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Aminopterin oral capsule
LD-Aminopterin tablets (0.5 mg tablet) over-encapsulated, 3.0 mg (6 tablets) once orally each week for 14 weeks (14 doses).
Drug: Aminopterin oral capsule
Placebo Comparator: Placebo oral capsule
Placebo capsules containing microcrystalline once orally each week for 14 weeks (14 doses).
Drug: Placebo oral capsule
Microcrystalline filled capsule to mimic capsule containing aminopterin tablets
Other Name: Placebo (for aminopterin)
- Psoriasis Area and Severity Index (PASI) (Efficacy) [ Time Frame: 98 days. ]
- Area of Involvement. Determine a score, from 0 to 6, for each body section (head, trunk, upper limbs, lower limbs) based on the percent of psoriasis skin involvement: 0=0%, 1=<10%, 2=10% to <30%, 3=30% to <50%, 4=50% to <70%, 5=70% to <90%, 6=90% to 100%.
- Severity of Involvement. Determine a score, from 0 to 4, for each body section (head, trunk, upper limbs, lower limbs), for the psoriatic skin severity of each of erythema, thickness, and scaling: 0=none, 1=slight, 2=moderate, 3=severe, 4=very severe. For each body section the three severity scores are summed.
- For each body section the product of the Area and Severity is determined.
- For each body section the product of line 3 is multiplied by an Area Factor (head=0.1, trunk=0.3, upper limbs=0.2, lower limbs=0.4).
- A PASI score is determined by summing the 4 body section products (line 4). The highest possible score=72; the lowest possible score=0. The higher the scores, the worse the psoriasis.
- Static Physician Global Assessment (sPGA) (Efficacy) [ Time Frame: 98 days. ]
- Induration. A score, from 0 to 5, based on: 0=No plaque elevation; 1= Minimal plaque elevation=0.25 mm; 2=Mild plaque elevation=0.5 mm; 3=Moderate plaque elevation=0.75 mm; 4=Marked plaque elevation=1.0 mm; 5=Severe plaque elevation>1.25 mm.
- Erythema. A score, from 0 to 5, based on: 0=No erythema, hyperpigmentation may be present; 1=Faint erythema; 2=Light red coloration; 3=Moderate red coloration; 4=Bright red coloration; 5=Dusky to deep red coloration.
- Scaling. A score, from 0 to 5, based on: 0= No scaling; 1=Minimal; occasional fine scale on<5% of the lesion; 2=Mild; fine scale predominates; 3=Moderate; coarse scale predominates; 4=Marked; thick, non-tenacious scale predominates; 5=Severe; very thick, tenacious scale predominates.
- The sPGA: Induration, Erythema, and Scaling scores are rounded to the nearest whole number and averaged. 0=Cleared; 1=Minimal; 2=Mild; 3=Moderate; 4=Marked; 5=Severe. Higher score indicates worse psoriasis.
- Analysis of Treatment Emergent Adverse Events [ Time Frame: 140 days. ]Analysis of treatment emergent adverse events to include incidence, severity, and relationship to study drug treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431974
|Contact: Stuart Kahn, MD||253-833-8009 ext firstname.lastname@example.org|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85255|
|Contact: Jenna Sanford 480-398-1550 email@example.com|
|Principal Investigator: Brenda LaTowsky, MD|
|United States, Washington|
|Premier Clinical Research||Recruiting|
|Spokane, Washington, United States, 99202|
|Contact: Kim Walter, CCRC 509-343-3710 ext 1135 KWalter@premierclinicalresearch.com|
|Contact: Kristyn R Aalto 509-343-3710 ext 1152 firstname.lastname@example.org|
|Principal Investigator: William P Werschler, M.D.|
|Study Director:||Stuart Kahn, MD||Syntrix Biosystems|