New pill shows promise for psoriasis in early trial
NCT ID NCT06073119
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
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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
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Oct 2023
- Finished
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Dec 2024
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Center for Clinical Studies, LTD, LLP- Site Number : 8400013
Webster, Texas, 77598, United States
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Center for Clinical Studies, LTD. LLP- Site Number : 8400007
Houston, Texas, 77004, United States
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Daxia Trials Site Number : 8400022
Boca Raton, Florida, 33431, United States
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Dermatology Research Associates- Site Number : 8400019
Los Angeles, California, 90045, United States
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Direct Helpers Medical Center Inc- Site Number : 8400023
Hialeah, Florida, 33012, United States
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Driven Research, LLC- Site Number : 8400012
Coral Gables, Florida, 33134, United States
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FXM Clinical Research Ft. Lauderdale, LLC Site Number : 8400015
Fort Lauderdale, Florida, 33308, United States
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FXM Clinical Research Miami, LLC- Site Number : 8400016
Miami, Florida, 33175, United States
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Investigational Site Number : 0320001
Buenos Aires, Buenos Aires F.D., 1060, Argentina
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Investigational Site Number : 0320002
CABA, Buenos Aires F.D., C1425DKG, Argentina
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Investigational Site Number : 0320003
CABA, Buenos Aires, C1023AAB, Argentina
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Investigational Site Number : 1000001
Sofia, 1404, Bulgaria
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Investigational Site Number : 1240002
Waterloo, Ontario, N2J 1C4, Canada
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Investigational Site Number : 1240006
London, Ontario, N6H 5L5, Canada
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Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7640881, Chile
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Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8420383, Chile
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Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7580206, Chile
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Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 8330034, Chile
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Investigational Site Number : 1560001
Hangzhou, 310009, China
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Investigational Site Number : 1560002
Wuxi, 610017, China
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Investigational Site Number : 2030003
Brno, 602 00, Czechia
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Investigational Site Number : 2680001
Tbilisi, 0179, Georgia
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Investigational Site Number : 2680002
Batumi, 6000, Georgia
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Investigational Site Number : 2760001
Frankfurt am Main, 60590, Germany
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Investigational Site Number : 2760002
Witten, 58453, Germany
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Investigational Site Number : 2760004
Blankenfelde-Mahlow, 15827, Germany
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Investigational Site Number : 3480002
Debrecen, 4032, Hungary
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Investigational Site Number : 3480003
Budapest, 1083, Hungary
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Investigational Site Number : 3920001
Yokohama, 221-0825, Japan
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Investigational Site Number : 3920002
Tachikawa-shi, Tokyo, 190-0023, Japan
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Investigational Site Number : 3920003
Sakai-shi, Osaka, 593-8324, Japan
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Investigational Site Number : 3920004
Kamimashiki Gun, Kumamoto, 861-3106, Japan
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Investigational Site Number : 3920005
Ichikawa-shi, 272-0033, Japan
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Investigational Site Number : 3920006
Itabashi-ku, Tokyo, 173-8610, Japan
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Investigational Site Number : 4800001
Quatre Bornes, 72218, Mauritius
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Investigational Site Number : 6160001
Bydgoszcz, 85-796, Poland
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Investigational Site Number : 6160002
Katowice, 40-081, Poland
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Investigational Site Number : 6200001
Lisbon, 1998-018, Portugal
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Investigational Site Number : 6200002
Lisbon, 1649-035, Portugal
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Investigational Site Number : 6200003
Guimarães, 4810-061, Portugal
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Investigational Site Number : 7240002
Zaragoza, 50009, Spain
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Investigational Site Number : 7240003
Manises, Valencia, 46940, Spain
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Investigational Site Number : 7240004
Madrid, 28041, Spain
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Investigational Site Number : 7240005
Madrid, 28040, Spain
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Investigational Site Number : 7240007
Alicante, 03010, Spain
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Investigational Site Number : 7920001
Kayseri, 38039, Turkey (Türkiye)
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Investigational Site Number : 7920002
Antalya, 07070, Turkey (Türkiye)
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Investigational Site Number : 8260001
Manchester, M23 9QZ, United Kingdom
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Jordan Valley Dermatology Center- Site Number : 8400027
South Jordan, Utah, 84095, United States
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Renaissance Research and Medical Group, Inc- Site Number : 8400018
Cape Coral, Florida, 33991, United States
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Scottsdale Clinical Trials Site Number : 8400025
Scottsdale, Arizona, 85260, United States
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