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PsoriasisPhase 2SPECIFI-PSONCT06073119

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

A Phase 2 study testing SAR441566 in people with Psoriasis, run by Sanofi at 51 sites in 17 countries.

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 was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
SAR441566
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
51 sitesin 17 countries
Study dates
26 Oct 2023to 11 Dec 2024
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

51 sites in 17 countries.

51 sites in 17 countries

United States11 sites

  • Daxia Trials Site Number : 8400022

    Boca Raton, Florida, 33431

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

    Cape Coral, Florida, 33991

  • Driven Research, LLC- Site Number : 8400012

    Coral Gables, Florida, 33134

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

    Fort Lauderdale, Florida, 33308

  • Direct Helpers Medical Center Inc- Site Number : 8400023

    Hialeah, Florida, 33012

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

    Houston, Texas, 77004

  • Dermatology Research Associates- Site Number : 8400019

    Los Angeles, California, 90045

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

    Miami, Florida, 33175

  • Scottsdale Clinical Trials Site Number : 8400025

    Scottsdale, Arizona, 85260

  • Jordan Valley Dermatology Center- Site Number : 8400027

    South Jordan, Utah, 84095

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

    Webster, Texas, 77598

Other trials in United States

Japan6 sites

  • Investigational Site Number : 3920005

    Ichikawa-shi, 272-0033

  • Investigational Site Number : 3920004

    Kamimashiki Gun, Kumamoto, 861-3106

  • Investigational Site Number : 3920003

    Sakai-shi, Osaka, 593-8324

  • Investigational Site Number : 3920006

    tabashi City, Tokyo, 173-8610

  • Investigational Site Number : 3920002

    Tachikawa-shi, Tokyo, 190-0023

  • Investigational Site Number : 3920001

    Yokohama, 221-0825

Other trials in Japan

Spain5 sites

  • Investigational Site Number : 7240007

    Alicante, 03010

  • Investigational Site Number : 7240005

    Madrid, 28040

  • Investigational Site Number : 7240004

    Madrid, 28041

  • Investigational Site Number : 7240003

    Manises, Valencia, 46940

  • Investigational Site Number : 7240002

    Zaragoza, 50009

Other trials in Spain

Chile4 sites

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8330034

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8420383

Other trials in Chile

Argentina3 sites

  • Investigational Site Number : 0320001

    Buenos Aires, Buenos Aires F.D., 1060

  • Investigational Site Number : 0320003

    CABA, Buenos Aires, C1023AAB

  • Investigational Site Number : 0320002

    CABA, Buenos Aires F.D., C1425DKG

Other trials in Argentina

Germany3 sites

  • Investigational Site Number : 2760004

    Blankenfelde-Mahlow, 15827

  • Investigational Site Number : 2760001

    Frankfurt am Main, 60590

  • Investigational Site Number : 2760002

    Witten, 58453

Other trials in Germany

Portugal3 sites

  • Investigational Site Number : 6200003

    Guimarães, 4810-061

  • Investigational Site Number : 6200002

    Lisbon, 1649-035

  • Investigational Site Number : 6200001

    Lisbon, 1998-018

Other trials in Portugal

Canada2 sites

  • Investigational Site Number : 1240006

    London, Ontario, N6H 5L5

  • Investigational Site Number : 1240002

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

China2 sites

  • Investigational Site Number : 1560001

    Hangzhou, 310009

  • Investigational Site Number : 1560002

    Wuxi, 610017

Other trials in China

Georgia2 sites

  • Investigational Site Number : 2680002

    Batumi, 6000

  • Investigational Site Number : 2680001

    Tbilisi, 0179

Other trials in Georgia

Hungary2 sites

  • Investigational Site Number : 3480003

    Budapest, 1083

  • Investigational Site Number : 3480002

    Debrecen, 4032

Other trials in Hungary

Poland2 sites

  • Investigational Site Number : 6160001

    Bydgoszcz, 85-796

  • Investigational Site Number : 6160002

    Katowice, 40-081

Other trials in Poland

Turkey (Türkiye)2 sites

  • Investigational Site Number : 7920002

    Antalya, 07070

  • Investigational Site Number : 7920001

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Bulgaria1 site

  • Investigational Site Number : 1000001

    Sofia, 1404

Other trials in Bulgaria

Czechia1 site

  • Investigational Site Number : 2030003

    Brno, 602 00

Other trials in Czechia

Mauritius1 site

  • Investigational Site Number : 4800001

    Quatre Bornes, 72218

Other trials in Mauritius

United Kingdom1 site

  • Investigational Site Number : 8260001

    Manchester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Plaque Psoriasis

This was a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It was designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details included a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (4 weeks ± 3 days). The total number of study visits was 7.

Read the detailed description

The overall study duration for each participant was up to 149 days.

Conditions
Psoriasis
Being tested
SAR441566, Placebo
Medical subject headings
Psoriasis

What participants receive

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

  • SAR441566Drug

    Tablet

  • PlaceboDrug

    Tablet

Study groups in NCT06073119
Study groupRoleWhat they receive
SAR441566 dose regimen AExperimentalParticipants received dose regimen A of SAR441566
Receives: Drug: SAR441566
SAR441566 dose regimen BExperimentalParticipants received dose regimen B of SAR441566
Receives: Drug: SAR441566
SAR441566 dose regimen CExperimentalParticipants received dose regimen C of SAR441566
Receives: Drug: SAR441566
SAR441566 dose regimen DExperimentalParticipants received dose regimen D of SAR441566
Receives: Drug: SAR441566
SAR441566 dose regimen EExperimentalParticipants received dose regimen E of SAR441566
Receives: Drug: SAR441566
PlaceboPlacebo comparatorParticipants received SAR441566 matching placebo
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12

    PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.

    Measured: Baseline (Day 1) and Week 12

Secondary outcomes (5)

  1. Percent Change From Baseline in Psoriasis Area and Severity Index to Week 12

    PASI is linear combination of percent of surface area of skin that is affected and severity of E, i, D over 4 body regions: h, t, u, l. The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range: 0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax": 0= no involvement,1= <10% to 6 =90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. The PASI score ranges from 0 (no disease) to 72 (maximal disease); higher scores indicate greater psoriasis severity. Baseline was defined as last available value before the first dose of study treatment.

    Measured: Baseline (Day 1) to Week 12

  2. Percentage of Participants With Static Psoriasis Global Assessment (sPGA) Score 0 (Complete Clearance) or 1 (Minimal Disease) at Week 12

    sPGA is 5-point score based on average thickness,erythema,and scaling of all psoriatic lesions.Score ranges:E:0(normal) to 4(bright to deep red coloration of lesions); i (plaque elevation):0(none) to 4(severe thickening with hard edges; D:0(no scaling) to 3(moderate scaling).Overall scoring: average of E,i,D;range:0(clear)= 0 for all 3 symptoms; 1(almost clear)=mean >0, <1.5, normal to pink coloration, just detectable(possible slight elevation),no to minimal focal scaling; 2(mild)= mean >= 1.5, <2.5, pink to light red coloration, mild thickening, predominantly fine scaling; 3(moderate)= mean >=2.5,<3.5, dull to bright red coloration, clearly distinguishable to moderate thickening, moderate scaling; 4(severe)= mean >=3.5,bright to deep dark red coloration,severe thickening with hard edges,severe coarse scaling covering almost all or all lesions.Lower score:less body coverage,with 0:complete clearance and 1:minimal disease. Total participants who received score of 0 and 1 are reported.

    Measured: Baseline (Day 1) and Week 12

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Study Treatment Discontinuation and Study Withdrawals Due to TEAEs

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were AEs that developed, worsened or became serious during the TE period. An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.

    Measured: From first dose of study treatment (Day 1) up to 5 days post last dose of study treatment, up to 102 days

  4. Pre-Dose Plasma Concentration of SAR441566

    Blood samples were collected at indicated timepoints for the assessment of pre-dose plasma concentration of SAR441566.

    Measured: 1 hour pre-dose on Weeks 2, 4, 8 and 12

  5. Post-Dose Plasma Concentration of SAR441566

    Blood samples were collected at indicated timepoints for the assessment of post-dose plasma concentration of SAR441566.

    Measured: 2.5 to 3.5 hours post-dose on Day 1, Weeks 2, 4, 8 and 12

Timeline

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

  1. First posted10 Oct 2023
  2. Study start26 Oct 2023
  3. Primary completion13 Nov 2024
  4. Study completion11 Dec 2024

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06073119
Sponsor's protocol ID
DRI17849
Other IDs
2023-503911-14, U1111-1290-5787, 2023-503911-14-00, 2023-503911-14, 2023
Acronym
SPECIFI-PSO
Status last verified
Oct 2025
First submitted
4 Oct 2023
Last updated
10 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR441566 in people with Psoriasis, run by Sanofi at 51 sites in 17 countries.

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 6 inclusion and 22 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Japan, Spain, Chile, Argentina and 12 more countries. 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 10 Nov 2025). 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?

Percentage of Participants With a 75% or Greater Psoriasis Area and Severity Index (PASI) Score Reduction From Baseline (PASI75) at Week 12 (time frame: Baseline (Day 1) and Week 12). 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 NCT06073119.

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 10 Nov 2025.

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