Arthritis, PsoriaticPhase 3IZAR-2NCT06641089
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
A Phase 3 study testing Sonelokimab and Risankizumab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 143 sites in 11 countries.
Trial summary
This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α 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 and Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 143 sitesin 11 countries
- Study dates
- 15 Oct 2024to 13 Sep 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.
- Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.
Who cannot join
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- 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 biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
Trial locations and contacts
143 sites in 11 countries.
143 sites in 11 countries
United States44 sites
Clinical Site
Allen, Texas, 75013
Clinical Site
Austin, Texas, 78745
Clinical Site
Avon Park, Florida, 33825
Clinical Site
Avondale, Arizona, 85392
Clinical Site
Baltimore, Maryland, 21224-6821
Clinical Site
Baytown, Texas, 77521
Clinical Site
Beckley, West Virginia, 25801
Clinical Site
Brooklyn, New York, 11201
Clinical Site
Chandler, Arizona, 85225
Clinical Site
Charlotte, North Carolina, 28262
Clinical Site
Clearwater, Florida, 33765
Clinical Site
Colleyville, Texas, 76034
Clinical Site
Duncansville, Pennsylvania, 16635
Clinical Site
Flagstaff, Arizona, 86001
Clinical Site
Gainesville, Georgia, 30501
Clinical Site
Grand Blanc, Michigan, 48439-2451
Clinical Site
Hialeah, Florida, 33016
Clinical Site
Houston, Texas, 77089
Clinical Site
Jackson, Tennessee, 38305
Clinical Site
Jonesboro, Arkansas, 72401
Clinical Site
La Jolla, California, 92037
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
Miami Gardens, Florida, 33014
Clinical Site
Middleburg Heights, Ohio, 44130
Clinical Site
Murfreesboro, Tennessee, 37128
Clinical Site
Phoenix, Arizona, 85032
Clinical Site
Plano, Texas, 75024
Clinical Site
Pomona, California, 91767
Clinical Site
Portland, Oregon, 97239
Clinical Site
Rochester, New York, 14642
Clinical Site
San Diego, California, 92108
Clinical Site
Santa Monica, California, 90404
Clinical Site
Scottsdale, Arizona, 85260
Clinical Site
Seattle, Washington, 98122
Clinical Site
Springfield, Illinois, 62702
Clinical Site
Tampa, Florida, 33607
Clinical Site
Thousand Oaks, California, 91360
Clinical Site
Tucson, Arizona, 85748
Clinical Site
Upland, California, 91786
Clinical Site
Zephyrhills, Florida, 33542
Poland27 sites
Clinical Site
Bialystok, 15707
Clinical Site
Bydgoszcz, 85-065
Clinical Site
Częstochowa, 42-202
Clinical Site
Elblag, 82-300
Clinical Site
Gdynia, 81-384
Clinical site
Katowice, 40-282
Clinical Site
Krakow, 30-002
Clinical Site
Krakow, 30-149
Clinical Site
Krakow, 31-501
Clinical Site
Lodz, 91-363
Clinical Site
Nadarzyn, 05-830
Clinical Site
Poznan, 60-324
Clinical Site
Poznan, 60-446
Clinical Site
Poznan, 60-693
Clinical Site
Poznan, 61-397
Clinical Site
Sochaczew, 96-500
Clinical Site
Swidnica, 58100
Clinical Site
Warsaw, 00-874
Clinical Site
Warsaw, 02-118
Clinical Site
Warsaw, 02-665
Clinical Site
Warsaw, 02-677
Clinical Site
Warsaw, 02-786
Clinical Site
Warsaw, 03-291
Clinical Site
Warsaw, 04-305
Clinical Site
Wołomin, 05-200
Clinical Site
Wroclaw, 51-685
Clinical Site
Wroclaw, 53-673
Spain13 sites
Clinical Site
A Coruña, 15006
Clinical Site
Alcobendas, 28100
Clinical Site
Bilbao, 48013
Clinical Site
Castellon, 12004
Clinical Site
Madrid, 28003
Clinical Site
Málaga, 29009
Clinical SIte
Sabadell, 08208
Clinical Site
Santiago de Compostela, 15702
Clinical Site
Santiago de Compostela, 15706
Clinical Site
Seville, 41009
Clinical Site
Seville, 41010
Clinical Site
Seville, 41013
Clinical Site
Valencia, 46010
Bulgaria12 sites
Clinical Site
Pazardzhik, 4400
Clinical Site
Pleven, 5800
Clinical Site
Plovdiv, 4000
Clinical Site
Plovdiv, 4001
Clinical Site
Plovdiv, 4002
Clinical Site
Plovdiv, 4003
Clinical Site
Plovdiv, 4004
Clinical Site
Rousse, 7000
Clinical Site
Sofia, 1462
Clinical Site
Sofia, 1606
Clinical Site
Sofia, 1784
Clinical Site
Stara Zagora, 6003
Germany11 sites
Clinical Site
Berlin, 12161
Clinical Site
Berlin, 12203
Clinical Site
Berlin, 13125
Clinical Site
Dresden, 01067
Clinical Site
Erlangen, 91054
Clinical Site
Frankfurt, 60528
Clinical Site
Hamburg, 20095
Clinical Site
Herne, 44649
Clinical Site
München, 80336
Clinical Site
Munich, 80639
Clinical Site
Munich, 81667
Hungary9 sites
Clinical Site
Budapest, 1027
Clinical Site
Budapest, 1036
Clinical Site
Debrecen, H-4032
Clinical SIte
Gyula, 5700
Clinical Site
Hódmezővásárhely, 6800
Clinical Site
Nyíregyháza, 4400
Clinical Site
Székesfehérvár, 8000
Clinical Site
Szolnok, 5000
Clinical Site
Veszprém, 8200
Georgia8 sites
Clinical Site
Tbilisi, 0102
Clinical Site
Tbilisi, 0112
Clinical Site
Tbilisi, 0141
Clinical Site
Tbilisi, 0159
Clinical Site
Tbilisi, 0179
Clinical Site
Tbilisi, 0180
Clinical Site
Tbilisi, 0186
Clinical Site
Tbilisi
France6 sites
Clinical Site
Caluire-et-Cuire, 69300
Clinical Site
Montpellier, 34295
Clinical Site
Narbonne, 11100
Clinical Site
Nice, 06001
Clinical Site
Rouen, 76031
Clinical Site
Tours, 37170
Canada5 sites
Clinical Site
Calgary, T2N 4L7
Clinical Site
Toronto, Ontario, M5S1B2
Clinical Site
Trois-Rivières, G9A 3X2
Clinical Site
Waterloo, N2J 1C4
Clinical Site
Winnipeg, R3A IM3
Czechia4 sites
Clinical Site
Brno, 63800
Clinical Site
Ostrava, 70200
Clinical Site
Studénka, 742 13
Clinical Site
Zlín, 760 01
United Kingdom4 sites
Clinical Site
Barnet, EN5 3DJ
Clinical Site
Leeds, LS7 4SA
Clinical Site
Westcliff-on-Sea, Essex, SS0
Clinical Site
Wolverhampton, WV10 0QP
About this study
Official title: A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors
This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Read the detailed description
M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
- Conditions
- Arthritis, Psoriatic
- Being tested
- Sonelokimab, Placebo, Risankizumab
- 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
Sonelokimab
PlaceboDrug
Placebo
RisankizumabDrug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| sonelokimab dose 1 with an induction regimen | Experimental | Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8. Receives: Drug: Sonelokimab |
| sonelokimab dose 2 with an induction regimen | Experimental | Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8. Receives: Drug: Sonelokimab |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive placebo SC Receives: Drug: Placebo |
| risankizumab | Active comparator | Subjects randomized to this arm will receive risankizumab SC Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 compared to placebo
Secondary outcomes (6)
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 compared to placebo
Response rate of participants achieving Minimal Disease Activity (MDA)
Proportion of participants achieving MDA
Measured: Week 16 compared to placebo
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Change in HAQ-DI from baseline
Measured: Week 16 compared to placebo
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 compared to placebo
Short- form-36 (SF-36) Physical Component Summary (PCS)
Change from Baseline in SF-36 PCS at Week 16
Measured: Week 16 compared to placebo
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 compared to risankzumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024
- Primary completion4 Jan 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641089
- Sponsor's protocol ID
- M1095-PSA-302
- Acronym
- IZAR-2
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors
- ClinicalTrials.gov ID
- NCT06641089
- Acronym / sponsor ID
- IZAR-2 / M1095-PSA-302
- Conditions
- Arthritis, Psoriatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Detailed description
M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sonelokimab dose 1 with an induction regimen | Experimental | Drug: SonelokimabSubjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8. |
| sonelokimab dose 2 with an induction regimen | Experimental | Drug: SonelokimabSubjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will receive placebo SC |
| risankizumab | Active comparator | Drug: RisankizumabSubjects randomized to this arm will receive risankizumab SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonelokimabSonelokimab | Drug | sonelokimab dose 1 with an induction regimen, sonelokimab dose 2 with an induction regimen |
| PlaceboPlacebo | Drug | Placebo |
| RisankizumabActive comparator | Drug | risankizumab |
Primary outcome
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Time frame: Week 16 compared to placebo
Proportion of participants achieving ACR50
6 secondary outcomes
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Time frame: Week 16 compared to placebo
Response rate of participants achieving Minimal Disease Activity (MDA)
Time frame: Week 16 compared to placebo
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time frame: Week 16 compared to placebo
Psoriasis Area and Severity Index (PASI90)
Time frame: Week 16 compared to placebo
Short- form-36 (SF-36) Physical Component Summary (PCS)
Time frame: Week 16 compared to placebo
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Time frame: Week 16 compared to risankzumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
143 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sonelokimab and Risankizumab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 143 sites in 11 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 8 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 143 sites in United States, Poland, Spain, Bulgaria, Germany and 6 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 compared to placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.