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New pill shows promise for psoriasis in early trial

NCT ID NCT06073119

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new oral medication, SAR441566, in 221 adults with moderate to severe plaque psoriasis. Participants received either the drug or a placebo for 12 weeks. The main goal was to see if the drug could reduce psoriasis severity by at least 75%. Results will help determine 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 (tablet)
What this could lead to
If successful, this could lead to a new oral treatment option for people with moderate to severe plaque psoriasis.
What could go wrong
This is an early Phase 2 study with a small number of participants. The drug may not prove effective or safe enough to move forward.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

221 people

The number who actually took part.

Started

Oct 2023

Finished

Dec 2024

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 75 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: * Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and D1 (prior to randomization): * PASI ≥ 12 points; * and sPGA score ≥ 3 points; * and BSA score ≥ 10% * Had to be a candidate for phototherapy or systemic therapy. * Total body weight ≥ 50 kg (110 lb) and body mass index (BMI) within the range \[18 - 35\] kg/m\^2 (inclusive) Exclusion Criteria: * Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis was accepted for inclusion. * Plaque psoriasis was restricted to scalp, palms, soles, or flexures only. * Any other skin diseases that could interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection) * Other immunologic (autoimmune or inflammatory) disorder, except medically controlled diabetes or thyroid disorder as per Investigator's judgement * History of recurrent or recent serious infection (eg, pneumonia, septicemia), or infection(s) requiring hospitalization or treatment with IV antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1, or infections(s) requiring oral antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1 * Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration * Participant with personal or family history of long QT syndrome * History of moderate to severe congestive heart failure (New York Heart Association Class III or IV), or recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would have put the participant at risk by participation in the protocol * History of solid organ transplant * History of alcohol or drug abuse within the past 2 years * History of diagnosis of demyelinating disease such as but not limited to: * Multiple Sclerosis * Acute Disseminated Encephalomyelitis * Balo's Disease (Concentric Sclerosis) * Charcot-Marie-Tooth Disease * Guillain-Barre Syndrome * Human T-lymphotropic virus 1 Associated Myelopathy * Neuromyelitis Optica (Devic's Disease) * Planned surgery during the treatment period * Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin * Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) or planned to receive one during the trial The above information was 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

  • Center for Clinical Studies, LTD, LLP- Site Number : 8400013

    Webster, Texas, 77598, United States

  • Center for Clinical Studies, LTD. LLP- Site Number : 8400007

    Houston, Texas, 77004, United States

  • Daxia Trials Site Number : 8400022

    Boca Raton, Florida, 33431, United States

  • Dermatology Research Associates- Site Number : 8400019

    Los Angeles, California, 90045, United States

  • Direct Helpers Medical Center Inc- Site Number : 8400023

    Hialeah, Florida, 33012, United States

  • Driven Research, LLC- Site Number : 8400012

    Coral Gables, Florida, 33134, United States

  • FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015

    Fort Lauderdale, Florida, 33308, United States

  • FXM Clinical Research Miami, LLC- Site Number : 8400016

    Miami, Florida, 33175, United States

  • Investigational Site Number : 0320001

    Buenos Aires, Buenos Aires F.D., 1060, Argentina

  • Investigational Site Number : 0320002

    CABA, Buenos Aires F.D., C1425DKG, Argentina

  • Investigational Site Number : 0320003

    CABA, Buenos Aires, C1023AAB, Argentina

  • Investigational Site Number : 1000001

    Sofia, 1404, Bulgaria

  • Investigational Site Number : 1240002

    Waterloo, Ontario, N2J 1C4, Canada

  • Investigational Site Number : 1240006

    London, Ontario, N6H 5L5, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1560001

    Hangzhou, 310009, China

  • Investigational Site Number : 1560002

    Wuxi, 610017, China

  • Investigational Site Number : 2030003

    Brno, 602 00, Czechia

  • Investigational Site Number : 2680001

    Tbilisi, 0179, Georgia

  • Investigational Site Number : 2680002

    Batumi, 6000, Georgia

  • Investigational Site Number : 2760001

    Frankfurt am Main, 60590, Germany

  • Investigational Site Number : 2760002

    Witten, 58453, Germany

  • Investigational Site Number : 2760004

    Blankenfelde-Mahlow, 15827, Germany

  • Investigational Site Number : 3480002

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3480003

    Budapest, 1083, Hungary

  • Investigational Site Number : 3920001

    Yokohama, 221-0825, Japan

  • Investigational Site Number : 3920002

    Tachikawa-shi, Tokyo, 190-0023, Japan

  • Investigational Site Number : 3920003

    Sakai-shi, Osaka, 593-8324, Japan

  • Investigational Site Number : 3920004

    Kamimashiki Gun, Kumamoto, 861-3106, Japan

  • Investigational Site Number : 3920005

    Ichikawa-shi, 272-0033, Japan

  • Investigational Site Number : 3920006

    Itabashi-ku, Tokyo, 173-8610, Japan

  • Investigational Site Number : 4800001

    Quatre Bornes, 72218, Mauritius

  • Investigational Site Number : 6160001

    Bydgoszcz, 85-796, Poland

  • Investigational Site Number : 6160002

    Katowice, 40-081, Poland

  • Investigational Site Number : 6200001

    Lisbon, 1998-018, Portugal

  • Investigational Site Number : 6200002

    Lisbon, 1649-035, Portugal

  • Investigational Site Number : 6200003

    Guimarães, 4810-061, Portugal

  • Investigational Site Number : 7240002

    Zaragoza, 50009, Spain

  • Investigational Site Number : 7240003

    Manises, Valencia, 46940, Spain

  • Investigational Site Number : 7240004

    Madrid, 28041, Spain

  • Investigational Site Number : 7240005

    Madrid, 28040, Spain

  • Investigational Site Number : 7240007

    Alicante, 03010, Spain

  • Investigational Site Number : 7920001

    Kayseri, 38039, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Antalya, 07070, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Manchester, M23 9QZ, United Kingdom

  • Jordan Valley Dermatology Center- Site Number : 8400027

    South Jordan, Utah, 84095, United States

  • Renaissance Research and Medical Group, Inc- Site Number : 8400018

    Cape Coral, Florida, 33991, United States

  • Scottsdale Clinical Trials Site Number : 8400025

    Scottsdale, Arizona, 85260, United States

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