NCT03431974

Once-Weekly Oral Aminopterin for the Treatment of Subjects With Moderate-To-Severe Psoriasis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Syntrix Biosystems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the treatment of psoriasis with aminopterin. Participants will be treated for 14 weeks with either aminopterin or placebo followed. The participants will not know if they are being treated with aminopterin or placebo.

Detailed description

A Phase 2, multi-center, randomized, double-blind, placebo-controlled study enrolling subjects with moderate-to-severe psoriasis to investigate the safety and efficacy of LD-aminopterin (AMT) (3 mg (six 0.5 mg tablets). Forty-six subjects will be randomized to one of two parallel treatment arms: LD-AMT (3 mg) or placebo, in a 1:1 ratio. The endpoint analysis will include efficacy and safety. Randomized subjects will initially enter a 14-week treatment phase, followed by a 6-week post-treatment phase.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	LD-Aminopterin oral capsule	anti-folate treatment
DRUG	Placebo oral capsule	Microcrystalline filled capsule to mimic capsule containing aminopterin tablets

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2018-02-13
• Last updated: 2023-04-14
• Results posted: 2023-04-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study