- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Spectrum Dermatology
-
-
Washington
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Seattle, Washington, United States, 98101
- Dermatology Associates of Seattle
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Spokane, Washington, United States, 99202
- Premier Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be 18 years of age or older.
- Have a diagnosis of moderate-to-severe psoriasis for at least 6 months confirmed by a dermatologist, defined here as plaque-type psoriasis affecting a body surface area of >10% and a PASI of >10.
- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
- Ability to understand and sign written informed consent.
Heterosexually active men and women of childbearing potential must use two methods of contraception during the study (20 weeks) and for 90 days after study completion. The two methods of birth control may be used simultaneously in the same subject or simultaneously in both partners. The two birth control methods can be (a) 2 barrier methods or (b) a barrier method plus a hormonal method to prevent pregnancy.
Barrier methods include: condom (female or male), copper intrauterine device, sponge, or spermicide.
Hormonal Methods include: any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent, including oral, subcutaneous, intrauterine, or intramuscular agents.
- For pre-menopausal women, a negative pregnancy test, obtained within 1 week prior to first study drug dose and at study visits Week 0, Week 6, Week10, Week 14, and Week 20. If at any visit during the Treatment Phase (see Appendix A) a positive pregnancy test is returned, the subject will be discontinued from any further study drug.
- Negative serology for human immunodeficiency virus 1 and 2 (HIV1/2), hepatitis B and hepatitis C.
- The following screening laboratory blood tests must have the following values, or not clinically significant as determined by the PI and Medical Monitor: white blood cells (WBC) within normal limits (WNL); absolute neutrophil count > lower limit of normal; platelet count WNL; hemoglobin >10.0 g/dL; aspartate aminotransferase (AST) < 2.5 x the upper limit of normal.
- Adequate renal function: creatinine clearance estimated by Cockcroft-Gault formula >60 ml/min
Exclusion Criteria:
- Known history of hepatitis, HIV infection, interstitial lung disease.
- Greater than moderate alcohol consumption on a regular basis (moderate consumption for females is 1 drink or 1 glass of wine a day; for males is 2 drinks or 2 glasses of wine a day) and unwilling, or unable, to control consumption during the study period.
- Prior use of aminopterin (AMT).
Use of these biologic treatments in the time frames specified:
- Within 9 months of first study drug dose: ustekinumab (Stelara).
- Within 12 weeks of first study drug dose: any experimental therapy for psoriasis or rheumatoid arthritis.
- Within 8 weeks of first study drug dose: infliximab (Remicade), adalimumab (Humira).
- Within 4 weeks of first study drug dose: etanercept (Enbrel).
- Other biologic therapies will have discontinuation periods determined by 5x their half-life.
- Within 90 days prior to Day 0 and at any time while on study, the use of MTX.
- Within 4 weeks prior to randomization and at any time while on study, use of phototherapy (e.g., ultraviolet B (UVB), narrow band UVB, Goeckerman regimen, Ingram regimen, PUVA), systemic medications (e.g. acitretin, mycophenolate mofetil, tacrolimus/FK506, cyclosporine A, azathioprine, 6-thioguanine, sulfasalazine, hydroxyurea, calcitriol, any systemic immunosuppressants), lithium, or any treatments that could affect psoriasis or sPGA evaluations. Subjects are eligible 4 weeks after the last dose of any of the aforementioned treatments was received.
Within 2 weeks prior to randomization and at any time while on study, use of any topical medications or treatments that could affect psoriasis evaluations (e.g., corticosteroids, anthralin, vitamin D3/calcitriol and analogues such calcipotriene and tacalcitol, synthetic retinoids such as tazarotene, coal tar, and keratolytics such as salicylic acid, lactic acid and urea including those contained in over-the-counter medicated shampoos). Subjects are eligible 2 weeks after the last dose of any of the aforementioned treatments was received.
Note: Over-the-counter topical steroids will be permitted for use limited to the face, axilla, and/or genitalia, as needed. These topical medications should not be used within approximately 24 hours prior to study visits Day 0 and Day 98. Over-the-counter shampoos for the treatment of psoriasis of the scalp are also permitted.
- Use of emollients on the morning of the first (Week 0) study visit.
- Within 2 weeks prior to Study Day 0, or on Study Day 0, or at any time during the study, use of any of the following medications that may result in drug/drug interactions with AMT: trimethoprim with or without sulfamethoxazole; sulfonamides; sulfonylureas; pyrimethamine; tromethamine; salicylates; non-steroidal anti-inflammatory (NSAID) drugs including ibuprofen; dipyridamole; colchicine; probenecid; aminoglycosides; theophylline; phenytoin; and folinic acid (i.e., leucovorin).
- Known concurrent malignancy except basal or squamous cell skin carcinoma, or cervical carcinoma in situ.
- Concurrent participation in another clinical trial involving experimental treatment within 30 days of Study Day 0.
- Current and uncontrolled infection, cardiovascular, renal, pulmonary, hepatic or GI conditions that will interfere with the conduct of the trial or pose a morbid risk.
- Investigator's opinion that a concurrent disease or condition impairs the subject's ability to complete the trial: includes psychological, familial, sociological, geographical or medical conditions.
- Breast-feeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LD-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).
|
anti-folate treatment
Other Names:
|
Placebo Comparator: Placebo oral capsule
Placebo capsules containing microcrystalline once orally each week for 14 weeks (14 doses).
|
Microcrystalline filled capsule to mimic capsule containing aminopterin tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects With >=75% Reduction in Baseline Psoriasis Area and Severity Index (PASI) (Efficacy)
Time Frame: 98 days.
|
As follows:
|
98 days.
|
Success (Score of 0 or 1) in Static Physician Global Assessment (sPGA) (Efficacy)
Time Frame: 98 days.
|
As follows:
|
98 days.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMT-PSO-201
- 5U44AI114473 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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