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New psoriasis pill shows early promise in small safety trial

NCT ID NCT05453942

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new oral drug called SAR441566 in 38 adults with mild to moderate psoriasis. Participants took the drug or a placebo twice daily for 4 weeks. The main goal was to check safety and tolerability, while also looking at changes in skin lesion severity. Results will help decide if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR441566 (an oral drug taken twice a day)
What this could lead to
If it works, this could point toward a new daily pill to ease psoriasis symptoms.
What could go wrong
This is a very early Phase 1 trial with only 38 people, so it is mainly checking safety, not effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

38 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female with mild to moderate psoriatic participants, between 18 and 65 years of age, inclusive. * Body mass index between 18.0 and 35.0 kg/m2, inclusive (body weight not under 50.0 Kg). * Female participants who are only postmenopausal or are sterilized (e.g post-bilateral surgical oophorectomy not linked to a history of cancer) can be included in the study. * Participant must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, vital signs, ECG, clinical laboratories, and urinalysis. * Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months prior to screening with mild to moderate severity, defined as PASI ≤ 16. * Participant must have at least two lesions with TLSS≥4 at both screening and baseline excluding the scalp. Exclusion Criteria: * Pre-existing signs of skin atrophy, telangiectasia or striae in the affected area * Use of systemic immunosuppressants within 4 weeks of entering the study and during the entire study duration * Current evidence of non-plaque forms of psoriasis (e.g., erythrodermic, guttate or pustular), psoriatic arthritis * Currently evidence or suspicion of drug-induced psoriasis (e.g., new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * Use of any of the following therapies within 4 weeks prior to Baseline (Day 1): systemic non-biologic psoriasis therapies (including, but not limited to): psoralens and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, tofacitinib, oral retinoids, mycophenolate mofetil, sirolimus; or phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing) or topical psoriasis therapy with psoralens * Use of topical corticosteroid preparations (except hydrocortisone 1%), topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to randomization (Day 1) * Prior use of any biologicals for treatment of psoriasis * Participants who received any live vaccination within 3 months, any initial non-live vaccination within 30 days or non-live booster vaccination within 14 days of first IMP administration or intend to receive any vaccination during the study. * Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (including an ongoing biological proven SARS-CoV-2 infection and recurrent infection) or any condition that may affect participant safety in the judgment of the Investigator including participants who are not adequately vaccinated against a SARS-CoV-2 infection according to local regulations. * Opportunistic infections within 6 months before randomization (Day 1) The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigational Site Number :2760001

    Berlin, 10117, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.