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 : January 16, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431974
|Contact: Stuart Kahn, MD||253-833-8009 ext email@example.com|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85255|
|Contact: Jenna Sanford 480-398-1550 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Tiffany S Hanf, M.D.|
|Sub-Investigator: William P Werschler, M.D.|
|Study Director:||Stuart Kahn, MD||Syntrix Biosystems|