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PsoriasisPhase 2NCT03431974

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

A Phase 2 study testing LD-Aminopterin oral capsule in people with Psoriasis, run by Syntrix Biosystems, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
LD-Aminopterin oral capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
3 sitesUnited States
Study dates
1 Nov 2018to 11 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Spectrum Dermatology

    Scottsdale, Arizona, 85258

  • Dermatology Associates of Seattle

    Seattle, Washington, 98101

  • Premier Clinical Research

    Spokane, Washington, 99202

Other trials in United States

About this study

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

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.

Read the 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
Being tested
LD-Aminopterin oral capsule, Placebo oral capsule
Keywords
Anti-folate
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LD-Aminopterin oral capsuleDrug

    Also called racemic 4-Aminopteroylglutamic acid, racemic 4-Aminofolic acid

    anti-folate treatment

  • Placebo oral capsuleDrug

    Also called Placebo (for aminopterin)

    Microcrystalline filled capsule to mimic capsule containing aminopterin tablets

Study groups in NCT03431974
Study groupRoleWhat they receive
LD-Aminopterin oral capsuleExperimentalLD-Aminopterin tablets (0.5 mg tablet) over-encapsulated, 3.0 mg (6 tablets) once orally each week for 14 weeks (14 doses).
Receives: Drug: LD-Aminopterin oral capsule
Placebo oral capsulePlacebo comparatorPlacebo capsules containing microcrystalline once orally each week for 14 weeks (14 doses).
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjects With >=75% Reduction in Baseline Psoriasis Area and Severity Index (PASI) (Efficacy)

    As follows:

    1. 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%.
    2. 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.
    3. For each body section the product of the Area and Severity is determined.
    4. 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).
    5. 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.

    Measured: 98 days.

  2. Success (Score of 0 or 1) in Static Physician Global Assessment (sPGA) (Efficacy)

    As follows:

    1. 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.
    2. 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.
    3. 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.
    4. 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.

    Measured: 98 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2018
  2. Study start1 Nov 2018
  3. Primary completion11 Jan 2021
  4. Study completion11 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03431974
Sponsor's protocol ID
AMT-PSO-201
Other IDs
5U44AI114473
Status last verified
Mar 2023
First submitted
1 Feb 2018
Last updated
14 Apr 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Menter A, Thrash B, Cherian C, Matherly LH, Wang L, Gangjee A, Morgan JR, Maeda DY, Schuler AD, Kahn SJ, Zebala JA. Intestinal transport of aminopterin enantiomers in dogs and humans with psoriasis is stereoselective: evidence for a mechanism involving the proton-coupled folate transporter. J Pharmacol Exp Ther. 2012 Sep;342(3):696-708. doi: 10.1124/jpet.112.195479. Epub 2012 May 31.

    PubMed 22653877

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LD-Aminopterin oral capsule in people with Psoriasis, run by Syntrix Biosystems, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With >=75% Reduction in Baseline Psoriasis Area and Severity Index (PASI) (Efficacy) (time frame: 98 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03431974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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