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Arthritis, PsoriaticPhase 3IZAR-1NCT06641076

Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

A Phase 3 study testing Sonelokimab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 182 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Sonelokimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
960 participants
Where
182 sitesin 20 countries
Study dates
15 Oct 2024to 4 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Participants must be ≥18 years of age .
  • Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
  • Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
  • Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
  • Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

Who cannot join

  • Participants with a known hypersensitivity to sonelokimab or any of its excipients.
  • Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
  • Participants with a diagnosis of inflammatory bowel disease.
  • Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
  • Participants who have an established diagnosis of arthritis mutilans.
  • Previous exposure to sonelokimab.
  • Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.

Trial locations and contacts

182 sites in 20 countries.

182 sites in 20 countries

Poland44 sites

  • Clinical Site

    Bialystok, 15-879

  • Clinical Site

    Bialystok, 15707

  • Clinical Site

    Bydgoszcz, 85-065

  • Clinical Site

    Bydgoszcz, 85-168

  • Clinical Site

    Bytom, 41-902

  • Clinical Site

    Częstochowa, 42-202

  • Clinical Site

    Dąbrówka, 62-069

  • Clinical Site

    Dębica, 39-200

  • Clinical Site

    Elblag, 82-300

  • Clinical Site

    Gdynia, 81-384

  • Clinical Site

    Katowice, 40282

  • Clinical Site

    Krakow, 30-002

  • Clinical Site

    Krakow, 30-149

  • Clinical Site

    Krakow, 31-501

  • Clinical Site

    Lodz, 90-368

  • Clinical Site

    Lodz, 91-363

  • Clinical Site

    Lublin, 20-412

  • Clinical Site

    Lublin, 20-607

  • Clinical Site

    Nadarzyn, 05-830

  • Clinical Site

    Nowa Sól, 67-100

  • Clinical Site

    Olsztyn, 10-117

  • Clinical Site

    Poznan, 60-218

  • Clinical Site

    Poznan, 60-324

  • Clinical Site

    Poznan, 60-446

  • Clinical Site

    Poznan, 60-681

  • Clinical Site

    Poznan, 60-693

  • Clinical Site

    Poznan, 61-113

  • Clinical Site

    Poznan, 61-397

  • Clinical Site

    Siedlce, 08-110

  • Clinical Site

    Sochaczew, 96-500

  • Clinical Site

    Swidnica, 58100

  • Clinical Site

    Torun, 87-100

  • Clinical Site

    Warsaw, 00-874

  • Clinical Site

    Warsaw, 01-691

  • Clinical Site

    Warsaw, 02-118

  • Clinical Site

    Warsaw, 02-665

  • Clinical Site

    Warsaw, 02-677

  • Clinical Site

    Warsaw, 03-291

  • Clinical Site

    Warsaw, 04-305

  • Clinical Site

    Wołomin, 05-200

  • Clinical Site

    Wroclaw, 51-685

  • Clinical Site

    Wroclaw, 52-416

  • Clinical Site

    Wroclaw, 53-673

  • Clinical Site

    Zamość, 22400

Other trials in Poland

United States28 sites

  • Clinical Site

    Allen, Texas, 75013

  • Clinical Site

    Avon Park, Florida, 33825

  • Clinical Site

    Avondale, Arizona, 85392

  • Clinical Site

    Baltimore, Maryland, 21224-6821

  • Clinical Site

    Beckley, West Virginia, 25801

  • Clinical Site

    Chandler, Arizona, 85225

  • Clinical Site

    Clearwater, Florida, 33765

  • Clinical Site

    Colleyville, Texas, 76034

  • Clinical Site

    Flagstaff, Arizona, 86001

  • Clinical Site

    Grand Blanc, Michigan, 48439-2451

  • Clinical Site

    Hialeah, Florida, 33016

  • Clinical Site

    Lake Charles, Louisiana, 70605

  • Clinical Site

    Leland, North Carolina, 28451

  • Clinical Site

    Lubbock, Texas, 79424

  • Clinical Site

    Memphis, Tennessee, 38119

  • Clinical Site

    Mesa, Arizona, 85210

  • Clinical Site

    Middleburg Heights, Ohio, 44130

  • Clinical Site

    Phoenix, Arizona, 85032

  • Clinical Site

    Plano, Texas, 75024

  • Clinical Site

    Portland, Oregon, 97239

  • Clinical Site

    Salisbury, North Carolina, 28144

  • Clinical Site

    San Diego, California, 92108

  • Clinical Site

    Scottsdale, Arizona, 85260

  • Clinical Site

    Springfield, Illinois, 62702

  • Clinical Site

    Statesville, North Carolina, 28625

  • Clinical Site

    Tampa, Florida, 33607

  • Clinical Site

    Tucson, Arizona, 85748

  • Clinical Site

    Upland, California, 91786

Other trials in United States

Spain15 sites

  • Clinical Site

    A Coruña, 15006

  • Clinical Site

    Alcobendas, 28100

  • Clinical Site

    Bilbao, 48013

  • Clinical Site

    Castelló, 12004

  • Clinical Site

    Madrid, 28003

  • Clinical Site

    Madrid, 28046

  • Clinical Site

    Málaga, 29009

  • Clinical Site

    Sabadell, 08208

  • Clinical Site

    Santiago de Compostela, 15702

  • Clinical Site

    Santiago de Compostela, 15706

  • Clinical Site

    Seville, 41007

  • Clinical Site

    Seville, 41009

  • Clinical Site

    Seville, 41010

  • Clinical Site

    Seville, 41013

  • Clinical Site

    Valencia, 46007

Other trials in Spain

Hungary11 sites

  • Clinical SIte

    Budapest, 1023

  • Clinical Site

    Budapest, 1027

  • Clinical Site

    Budapest, 1036

  • Clinical Site

    Debrecen, H-4032

  • Clinical Site

    Gyula, 5700

  • Clinical Site

    Hódmezővásárhely, 6800

  • Clinical Site

    Kalocsa, 6300

  • Clinical Site

    Kistarcsa, 2143

  • Clinical Site

    Nyíregyháza, 4400

  • Clinical Site

    Székesfehérvár, 8000

  • Clinical Site

    Veszprém, 8200

Other trials in Hungary

Bulgaria10 sites

  • Clinical Site

    Pleven, 5800

  • Clinical Site

    Plovdiv, 4000

  • Clinical Site

    Plovdiv, 4001

  • Clinical Site

    Plovdiv, 4002

  • Clinical Site

    Plovdiv, 4004

  • Clinical Site

    Rousse, 7000

  • Clinical Site

    Sofia, 1463

  • Clinical Site

    Sofia, 1606

  • Clinical Site

    Sofia, 1784

  • Clinical Site

    Stara Zagora, 6003

Other trials in Bulgaria

Czechia10 sites

  • Clinical Site

    Břeclav, 690 02

  • Clinical Site

    Brno, 63800

  • Clinical Site

    Ostrava, 70200

  • Clinical Site

    Prague, 12850

  • Clinical Site

    Prague, 140 00

  • Clinical Site

    Prague, 140 59

  • Clinical Site

    Prague, 14800

  • Clinical Site

    Prague, 150 00

  • Clinical Site

    Studénka, 742 13

  • Clinical Site

    Zlín, 760 01

Other trials in Czechia

Germany10 sites

  • Clinical Site

    Bad Bentheim, 48455

  • Clinical Site

    Berlin, 12161

  • Clinical Site

    Berlin, 12203

  • Clinical Site

    Berlin, 13125

  • Clinical Site

    Erlangen, 91054

  • Clinical Site

    Hamburg, 20095

  • Clinical Site

    Herne, 44649

  • Clinical Site

    München, 80336

  • Clinical Site

    Munich, 80639

  • Clinical Site

    Munich, 81667

Other trials in Germany

Georgia9 sites

  • Clinical Site

    Kutaisi, 4600

  • Clinical Site

    Tbilisi, 0102

  • Clinical Site

    Tbilisi, 0112

  • Clinical Site

    Tbilisi, 0141

  • Clinical Site

    Tbilisi, 0159

  • Clinical Site

    Tbilisi, 0160

  • Clinical Site

    Tbilisi, 0179

  • Clinical Site

    Tbilisi, 0180

  • Clinical Site

    Tbilisi

Other trials in Georgia

France8 sites

  • Clinical Site

    Cahors, 46000

  • Clinical Site

    Caluire-et-Cuire, 69300

  • Clinical Site

    Échirolles, 38700

  • Clinical Site

    Montpellier, 34295

  • Clinical Site

    Narbonne, 11100

  • Clinical Site

    Nice, 06001

  • Clinical Site

    Rouen, 76031

  • Clinical Site

    Tours, 37170

Other trials in France

Romania6 sites

  • Clinical Site

    Bucharest, 011172

  • Clinical Site

    Bucharest, 012071

  • Clinical Site

    Bucharest, 020475

  • Clinical Site

    Bucharest, 030463

  • Clinical Site

    Bucharest, 041303

  • Clinical Site

    Timișoara, 300650

Other trials in Romania

Portugal5 sites

  • Clinical SIte

    Braga, 4700-000

  • Clinical Site

    Braga, 4710-243

  • Clinical Site

    Lisbon, 1500-458

  • Clinical Site

    Lisbon, 1649-035

  • Clinical Site

    Ponte de Lima, 4990-041

Other trials in Portugal

Canada4 sites

  • Clinical Site

    Calgary, T2N 4L7

  • Clinical Site

    Trois-Rivières, G9A 3X2

  • Clinical Site

    Waterloo, N2J 1C4

  • Clinical Site

    Winnipeg, R3A IM3

Other trials in Canada

Lithuania4 sites

  • Clinical Site

    Kaunas, 51270

  • Clinical Site

    Klaipėda, LT-92288

  • Clinical Site

    Šiauliai, 76231

  • Clinical Site

    Vilnius, 01117

Other trials in Lithuania

Slovakia4 sites

  • Clinical Site

    Košice, 04011

  • Clinical Site

    Martin, 036 01

  • Clinical Site

    Poprad, 058 01

  • Clinical Site

    Rimavská Sobota, 979 01

Other trials in Slovakia

Estonia3 sites

  • Clinical Site

    Tallinn, 10117

  • Clinical Site

    Tallinn, 13419

  • Clinical Site

    Tartu, 50708

Other trials in Estonia

Greece3 sites

  • Clinical Site

    Athens, Attica, 11521

  • Clinical Site

    Athens, 12462

  • Clinical Site

    Heraklion, 71110

Other trials in Greece

Serbia3 sites

  • Clinical Site

    Belgrade, 11000

  • Clinical Site

    Niška Banja, 18205

  • Clinical Site

    Novi Sad, 21000

Other trials in Serbia

Croatia2 sites

  • Clinical Site

    Rijeka, 51 000

  • Clinical Site

    Zagreb, 10000

Other trials in Croatia

Latvia2 sites

  • Clinical Site

    Adazi, LV2164

  • Clinical Site

    Riga, LV-1001

Other trials in Latvia

Finland1 site

  • Clinical Site

    Kuopio, 70100

Other trials in Finland

About this study

Official title: A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Read the detailed description

M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Being tested
Sonelokimab, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • SonelokimabDrug

    Randomized treatment, parallel-group

  • PlaceboDrug

    Randomized treatment, parallel-group

Study groups in NCT06641076
Study groupRoleWhat they receive
sonelokimab dose with an induction regimenExperimentalSubjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
Receives: Drug: Sonelokimab
sonelokimab dose without an induction regimenExperimentalSubjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
Receives: Drug: Sonelokimab
PlaceboPlacebo comparatorSubjects randomized to this arm will receive placebo subcutaneously.
Receives: Drug: Placebo

What is being measured

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

  1. Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)

    Proportion of participants achieving ACR50

    Measured: Week 16

Secondary outcomes (6)

  1. Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)

    Proportion of participants achieving ACR20

    Measured: Week 16

  2. Response rate of participants achieving Minimal Disease Activity (MDA)

    Proportion of participants achieving MDA

    Measured: Week 16

  3. Health Assessment Questionnaire- Disability Index (HAQ-DI)

    Change in HAQ-DI from baseline

    Measured: Week 16

  4. Psoriasis Area and Severity Index (PASI90)

    Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline

    Measured: Week 16

  5. Short- form-36 (SF-36) Physical Component Summary (PCS)

    Change from Baseline in SF-36 PCS at Week 16

    Measured: Week 16

  6. van der Heijde modified Total Sharp Score (vdHmTSS)

    Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS)

    Measured: Week 16

Timeline

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

  1. First posted15 Oct 2024
  2. Study start15 Oct 2024
  3. Primary completion28 May 2026
  4. Study completion4 Feb 2027 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06641076
Sponsor's protocol ID
M1095-PSA-301
Acronym
IZAR-1
Status last verified
Oct 2026
First submitted
11 Oct 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sonelokimab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 182 sites in 20 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in Poland, United States, Spain, Hungary, Bulgaria and 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) (time frame: Week 16). 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 NCT06641076.

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 9 Oct 2026.

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