Clinical trial • Phase III • Musculoskeletal
SONELOKIMAB for Psoriatic arthritis
Phase III trial of SONELOKIMAB for Psoriatic arthritis. open-label. 612 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Psoriatic arthritis
- Trial Stage
- Phase III
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 31-10-2025
- First CTIS Authorization Date
- 25-02-2026
Trial design
open-label Phase III trial in Bulgaria, Croatia, Czechia and others.
- Open Label
- Yes
- Target Sample Size
- 612
Eligibility
Recruits 612 Participants must be able to understand and provide signed informed consent per local regulations and guidelines. The trial metadata indicates vulnerable population selection is true, but no specific assent/parental consent procedures or under-18 enrolment provisions are provided in the submitted data; consent is to be obtained from participants themselves per local regulations..
- Pregnancy Exclusion
- 4. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential (WONCBP) or (if childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of treatment in this OLE study (Week 0). Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. NOTE: These precautions for contraception in WOCBP are required for 21 weeks after the last dose of study treatment in the parental study M1095-PsA-302, in case of study drug discontinuations occurring during the first 9 weeks of OLE. Additional precautions in WOCBP may also be required due to the use of any other concomitant medications.
- Vulnerable Population
- Participants must be able to understand and provide signed informed consent per local regulations and guidelines. The trial metadata indicates vulnerable population selection is true, but no specific assent/parental consent procedures or under-18 enrolment provisions are provided in the submitted data; consent is to be obtained from participants themselves per local regulations.
Inclusion criteria
- {"criterion_text":"- 1. Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study."}
- {"criterion_text":"- 2. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment (EOT) visit (Week 52) of the parental study."}
- {"criterion_text":"- 3. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study."}
- {"criterion_text":"- 4. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential (WONCBP) or (if childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of treatment in this OLE study (Week 0). Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. NOTE: These precautions for contraception in WOCBP are required for 21 weeks after the last dose of study treatment in the parental study M1095-PsA-302, in case of study drug discontinuations occurring during the first 9 weeks of OLE. Additional precautions in WOCBP may also be required due to the use of any other concomitant medications."}
- {"criterion_text":"- 5. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment."}
- {"criterion_text":"- 6. Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator."}
- {"criterion_text":"- 7. Participants are able to understand and provide signed informed consent, per local regulations and guidelines."}
Exclusion criteria
- {"criterion_text":"- 1. Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study."}
- {"criterion_text":"- 2. Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol."}
- {"criterion_text":"- 3. Participants who plan to participate in another interventional study for a drug or device during this study."}
- {"criterion_text":"- 4. Participants who were unblinded during the parental study."}
- {"criterion_text":"- 5. Participant noncompliance to the parental study (significant violation of protocol requirements or any other instances as per investigator’s judgement)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Serious adverse events (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- TEAEs leading to study withdrawal","definition_or_measurement_approach":""}
- {"endpoint_text":"- Adverse events of special interest (AESIs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Vital signs, and electrocardiogram (ECG) results","definition_or_measurement_approach":""}
- {"endpoint_text":"- Abnormal laboratory parameters (hematology, clinical chemistry)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 612
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent must be provided by participants themselves: "Participants are able to understand and provide signed informed consent, per local regulations and guidelines." Subject information and consent documents are available in multiple local languages (examples in submission include Bulgarian, Croatian, Czech, Estonian (and Russian), Finnish, French, German, Greek, Hungarian, Latvian (and Russian), Lithuanian, Polish, Portuguese, Romanian, Spanish, Slovak and others). No specific assent/parental-consent forms for minors are provided in the submitted materials.
Geography
- Total Number Of Participants
- 948
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 04-02-2026
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 30
- Number Of Participants
- 48
Croatia
- Earliest CTIS Part Ii Submission Date
- 06-02-2026
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 28
- Number Of Participants
- 5
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 25
- Number Of Participants
- 67
Estonia
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 6
- Number Of Participants
- 50
Finland
- Earliest CTIS Part Ii Submission Date
- 06-02-2026
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 25
- Number Of Participants
- 3
France
- Earliest CTIS Part Ii Submission Date
- 04-02-2026
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 22
- Number Of Participants
- 11
Germany
- Earliest CTIS Part Ii Submission Date
- 09-02-2026
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 24
- Number Of Participants
- 47
Greece
- Earliest CTIS Part Ii Submission Date
- 21-01-2026
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 35
- Number Of Participants
- 5
Latvia
- Earliest CTIS Part Ii Submission Date
- 09-02-2026
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 17
- Number Of Participants
- 28
Lithuania
- Earliest CTIS Part Ii Submission Date
- 24-02-2026
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 2
- Number Of Participants
- 11
Portugal
- Earliest CTIS Part Ii Submission Date
- 19-12-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 69
- Number Of Participants
- 6
Romania
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 7
- Number Of Participants
- 25
Spain
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 27
- Number Of Participants
- 45
Poland
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 07-03-2026
- Processing Time Days
- 33
- Number Of Participants
- 500
Slovakia
- Earliest CTIS Part Ii Submission Date
- 06-02-2026
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 25
- Number Of Participants
- 35
Hungary
- Earliest CTIS Part Ii Submission Date
- 21-11-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 97
- Number Of Participants
- 62
Sponsor
Primary sponsor
- Full Name
- MoonLake Immunotherapeutics AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- CRO
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- CRO
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Sonelokimab
- Active Substance
- SONELOKIMAB
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- 1
- Maximum Dose
- 120 mg (max daily); 1320 mg (max total)
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