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This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sonelokimab dose regimen 1 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1 |
|
| sonelokimab dose regimen 2 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2 |
|
| sonelokimab dose regimen 3 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3 |
|
| Placebo | Placebo Comparator | Subjects randomized to this arm will receive placebo |
|
| adalimumab | Active Comparator | Subjects randomized to this arm will receive adalimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | randomized treatment; parallel group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) | Proportion of participants who achieve ACR50 compared with baseline | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20) | Proportion of participants who achieve ACR20 compared with baseline | Week 2, 4, 8, 12 |
| Psoriasis Area and Severity Index (PASI) 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian Reich, M.D., Ph.D. (equ.) | MoonLake Immunotherapeutics AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Rancho Mirage | California | 92260 | United States | ||
| Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41053449 | Derived | McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF. Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. Nat Med. 2025 Dec;31(12):4160-4171. doi: 10.1038/s41591-025-03971-6. Epub 2025 Oct 6. |
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|
| Placebo | Drug | randomized treatment; parallel-group |
|
| Adalimumab | Drug | randomized treatment; parallel-group |
|
Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline |
| Week 4, 8, 12 |
| Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria | Proportion of participants who achieve ACR70 compared with baseline | Weeks 2, 4, 8, 12 |
| Leeds Enthesitis Index (LEI) | Proportion of participants with resolution of enthesitis (LEI = 0) | Weeks 4, 8, 12 |
| Leeds Dactylitis Index (LDI) | Change from baseline for Leeds Dactylitis Index | Weeks 4, 8, 12 |
| Modified Nail Psoriasis Severity Index (mNAPSI) | Change from baseline for mNAPSI | Week 12 |
| Psoriasis Area and Severity Index (PASI) 100 | Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline | Weeks 4, 8, 12 |
| Duncansville |
| Pennsylvania |
| 16635 |
| United States |
| Clinical Site | Pleven | 5800 | Bulgaria |
| Clinical Site | Pleven | 5803 | Bulgaria |
| Clinical Site | Plovdiv | 4002 | Bulgaria |
| Clinical Site | Plovdiv | 4003 | Bulgaria |
| Clinical Site | Rousse | 7002 | Bulgaria |
| Clinical Site | Sofia | 1336 | Bulgaria |
| Clinical Site | Stara Zagora | 6000 | Bulgaria |
| Clinical Site | Varna | 9000 | Bulgaria |
| Clinical Site | Ostrava | 702 00 | Czechia |
| Clinical Site | Tallinn | 10128 | Estonia |
| Clinical Site | Tartu | 20708 | Estonia |
| Clinical Site | Hamburg | 20095 | Germany |
| Clinical Site | Herne | 44649 | Germany |
| Clinical Site | Budapest | 1023 | Hungary |
| Clinical Site | Budapest | 1027 | Hungary |
| Clinical Site | Budapest | 1036 | Hungary |
| Clinical Site | Szentes | 6600 | Hungary |
| Clinical Site | Székesfehérvár | 8000 | Hungary |
| Clinical Site | Veszprém | 8200 | Hungary |
| Clinical Site | Bialystok | 15-077 | Poland |
| Clinical Site | Bialystok | 15-351 | Poland |
| Clinical Site | Bialystok | 15-879 | Poland |
| Clinical Site | Bydgoszcz | 85-065 | Poland |
| Clinical Site | Bydgoszcz | 85-168 | Poland |
| Clinical Site | Elblag | 82-300 | Poland |
| Clinical Site | Gdynia | 81-338 | Poland |
| Clinical Site | Krakow | 30-727 | Poland |
| Clinical Site | Lodz | 90-242 | Poland |
| Clinical Site | Nadarzyn | 05-830 | Poland |
| Clinical Site | Nowa Sól | 67-100 | Poland |
| Clinical Site | Olsztyn | 10-117 | Poland |
| Clinical Site | Poznan | 61-113 | Poland |
| Clinical Site | Sochaczew | 96-500 | Poland |
| Clinical Site | Swidnica | 58-100 | Poland |
| Clinical Site | Warsaw | 02-665 | Poland |
| Clinical SIte | Wroclaw | 52-416 | Poland |
| Clinical Site | Madrid | 28100 | Spain |
| Clinical Site | Sabadell | 8208 | Spain |
| Clinical Site | Santiago de Compostela | 15702 | Spain |
| Clinical Site | Seville | 41010 | Spain |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D012871 | Skin Diseases |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000720946 | sonelokimab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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