Phase 2 Open-Label Imaging Study of Sonelokimab in Active Psoriatic Arthritis and Axial Spondyloarthritis Using 68Ga-FAPI-46 PET/CT
- Trial ID
- 2024-514504-13-00
- Protocol
- M1095-snSpA-202
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this Phase 2, open-label imaging study is to evaluate the change in **disease activity** in patients with active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) by measuring the uptake of the [68Ga]-fibroblast activation protein inhibitor (FAPI) tracer on FAPI-positron emission tomography (PET)/low-dose computed tomography (CT) scans, specifically focusing on the standardized uptake value (SUVmax) per lesion at Week 12. This assessment is clinically relevant as it provides insights into the inflammatory activity and potential therapeutic effects of sonelokimab in these conditions.
Secondary objectives include:
- Assessing the change in disease activity as measured by 68Ga-FAPI tracer uptake (SUVmean) at Week 12.
- For PsA: Evaluating changes in inflammatory lesions via MRI or ultrasound, PsA symptoms, disease activity using clinical scores, psoriasis severity, nail psoriasis severity, physical function, enthesitis, dactylitis, and participant-reported outcomes (PROs) at Week 12.
- Assessing safety and tolerability over Week 16.
- Evaluating pharmacokinetics (PK) and immunogenicity.
- Assessing the effect of sonelokimab on biomarkers.
- For axSpA: Evaluating changes in inflammatory and structural lesions via MRI and FAPI-PET/low-dose CT, disease activity using clinical scores, physical function, enthesitis, and PROs at Week 12.
Participants
The clinical trial involves participants diagnosed with **psoriatic arthritis** and **axial spondyloarthritis**. The study population includes both male and female subjects, aged 18 years and older. Participants are required to be in good general health, aside from their specific medical conditions. The trial does not specify the total number of participants, as this information was not provided by the sponsor. Selection criteria include individuals with active disease symptoms and those who have shown inadequate response or intolerance to previous treatments. Participants must not be pregnant or breastfeeding and must agree to use effective contraception methods if of childbearing potential. The trial population includes individuals who are considered reliable and capable of adhering to the study protocol. Lifestyle considerations such as diet and physical activity are not explicitly mentioned, but participants must be able to comply with the study's requirements and restrictions. The trial includes a vulnerable population, indicating that additional ethical considerations are in place to protect these participants.
Plans and Procedures
The clinical trial is a **Phase 2, open-label** study designed to evaluate the effects of **sonelokimab** in patients with active **psoriatic arthritis** or **axial spondyloarthritis**. The primary objective is to assess changes in disease activity as measured by **68Ga-FAPI** tracer uptake on FAPI-PET/CT scans at Week 12. The trial involves the administration of **sonelokimab** via **subcutaneous injection** and **68Ga-FAPI-46** as a **solution for injection**. The study is expected to last until February 2026, with recruitment starting in March 2025.
Participants will undergo a series of study visits, beginning with a screening visit to confirm eligibility based on specific inclusion criteria, such as age, disease activity, and previous treatment history. The screening will also include a negative pregnancy test for women of childbearing potential. Following the screening, participants will receive the study treatment and attend regular follow-up visits to monitor disease activity and any adverse events. The end-of-study visit will occur at Week 12, where the primary endpoint, the change in **68Ga-FAPI SUVmax** signal, will be evaluated.
The expected duration of participant involvement is approximately 12 weeks, with conditions for early termination including significant adverse events or non-compliance with the study protocol. Participants must adhere to the visit schedule and medication intake as per the investigator's judgment. The study aims to provide comprehensive data on the efficacy and safety of **sonelokimab** in treating these conditions, with secondary endpoints including various measures of disease activity and quality of life assessments over the 12-week period.
Treatment
The clinical trial involves the administration of **Sonelokimab**, an experimental medication formulated as an **injection**. Sonelokimab is a protein-based therapeutic agent developed by Moonlake Immunotherapeutics AG. It is administered via **subcutaneous injection**. The dosage regimen for Sonelokimab is set at a maximum daily dose of 60 mg/ml, with a total maximum dose of 300 mg/ml over the treatment period. The treatment duration is capped at 8 weeks. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the protocol.
Additionally, the study utilizes **68Ga-FAPI-46**, a solution for injection, as an auxiliary agent. This compound is a chemical substance also developed by Moonlake Immunotherapeutics AG. It is administered through **injection** with a maximum daily dose of 200 MBq and a total maximum dose of 400 MBq. The administration period for 68Ga-FAPI-46 is limited to 2 weeks. This agent is used to assess changes in disease activity through imaging techniques, specifically FAPI-PET/CT scans. The administration and dosing of 68Ga-FAPI-46 are carefully monitored to ensure accurate imaging results and participant safety.
Efficacy
The efficacy of the clinical trial will be assessed by evaluating the change in disease activity in patients with active psoriatic arthritis or axial spondyloarthritis. The primary endpoint for efficacy is the change from baseline in **68Ga-FAPI** standardized uptake value (SUVmax) signal per lesion at Week 12, as detected by FAPI-positron emission tomography (PET)/low-dose computed tomography (CT) scan. Secondary endpoints include changes from baseline in **68Ga-FAPI** SUVmean signal at Week 12, and various disease-specific measures for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).
For PsA, secondary endpoints include changes in the psoriatic arthritis magnetic resonance imaging scoring system (PsAMRIS), global OMERACT EULAR ultrasound synovitis score (GLOESS), and the proportion of participants achieving American College of Rheumatology (ACR) responses (ACR20, ACR50, ACR70, and ACR90) at Week 12. Additional measures include changes in disease activity in psoriatic arthritis (DAPSA) score, psoriatic arthritis disease activity score (PASDAS), and other relevant clinical scores over 12 weeks.
For axSpA, secondary endpoints include changes from baseline in the number of sacroiliac joint (SIJ) quadrants and vertebral corners with **68Ga-FAPI** uptake at Week 12, as well as changes in SPARCC MRI score in SIJ and spine. The proportion of participants achieving assessment of spondyloarthritis international society (ASAS) responses (ASAS20 and ASAS40) and changes in ankylosing spondylitis disease activity score (ASDAS)-C-Reactive Protein (CRP) over 12 weeks will also be evaluated.
Efficacy assessments will be conducted using validated imaging techniques and clinical scoring systems at specified timepoints, primarily at Week 12. The data collected will be analyzed to determine the efficacy of the investigational product, Sonelokimab, in reducing disease activity in the target patient population.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants must be ≥18 years of age at the time of signing the informed consent form (ICF).
- PsA only: Participant tests negative for anti-cyclic citrullinated peptide antibodies at Screening.
- PsA only: Participant should have active PsA and must have at least 1 of the following: Inadequate response to previous or current treatment with ≥1 non-biologic conventional DMARD (csDMARDs) at the maximally tolerated dose given for at least 12 weeks. Intolerance to csDMARDs administration. Contraindication(s) to csDMARD therapy.
- axSpA only: Participant has nr-axSpA diagnosis with all of the following criteria (2009), adult-onset axSpA meeting ASAS classification criteria, inflammatory back pain for at least 3 months, age at symptom onset of less than 45 years, show disease activity on MRI in the SIJ or spine (observed within 8 weeks prior to Baseline) or positive C-Reactive protein (CRP) but NO radiographic evidence of sacroiliitis (in anterior-posterior pelvis or sacroiliac x-ray, not older than 12 months) OR Diagnosis of r-axSpA by the treating rheumatologist and classification based on the presence of radiographic damage in the SIJ and according to the ASAS classification criteria with documented radiologic evidence (observed within 1 year prior to Screening).
- axSpA only: Evidence of active disease, based on a BASDAI score of ≥4 despite treatment with a full dose of at least 2 NSAIDs for ≥4 weeks prior to Screening.
- axSpA only: Presence of signs of active disease on MRI of the SIJ or spine conducted within 8 weeks prior to Baseline.
- axSpA only: SIJ radiographs, taken from routine visit, must be available within 12 months prior to Screening, to determine the presence of radiographic changes in the SIJ.
- Positive FAPI-PET/CT (i.e., indication of high mesenchymal inflammatory disease activity).
- Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or, if women of 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 serum human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Week 0/Day 1 prior to the first administration of study treatment. See Appendix 4: Contraceptive and Barrier Guidance for the definition of nonchildbearing potential, childbearing potential, and highly effective methods of contraception.
- Male participants must be willing to use a condom when sexually active with a WOCBP partner during the study and for at least 12 weeks after the last dose of study treatment, unless surgically sterile.
- Participants are considered reliable and capable of adhering to the protocol, visit schedule, or medication intake, according to the judgment of the investigator and must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- PsA only: Participant has a confirmed diagnosis of PsA per the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥3 months prior to Screening.
- PsA only: Participant has evidence of active disease (defined by a TJC68 of ≥1 and a SJC66 of ≥1, OR ≥1 entheseal swelling or pain).
- PsA only: Signs of inflammation (enthesitis, tendinitis, synovitis, dactylitis) in clinical investigation and/or ultrasound and/or MRI, maximum 8 weeks prior to baseline
- PsA only: Participant has either current active psoriasis, nail changes consistent with psoriasis, or a history of psoriasis.
Exclusion Criteria
- Participants with a known hypersensitivity to sonelokimab or any of its excipients; participants with a known hypersensitivity to 68Ga-FAPI or any of its excipients.
- Participants with evidence of TB infection (active, history of active, latent or history of latent) at Screening. Participants may still enter the study if they have documented evidence that they have completed sufficient treatment, according to local routine clinical practice, at least 4 weeks before randomization. If they completed their treatment at least 4 weeks before and within 24 months of the Baseline Visit, to be enrolled they need to have documented evidence of treatment and have no evidence of active or latent disease. If they completed their treatment over 24 months before baseline, to be enrolled they need to have been adequately treated and confirmed to be fully recovered upon consultation with a TB specialist (see Section 8.1.3).
- Participants with any current nontuberculous mycobacterial infection or any history of nontuberculous mycobacterial infection at Screening.
- Participants with a concurrent acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the Screening.
- Participants with evidence of human immunodeficiency virus (HIV) infection at Screening.
- Participants with a concurrent malignancy or a history of malignancy within 5 years of the initiation of study treatment with the following exceptions: a. Three or fewer successfully excised or ablated basal cell carcinomas of the skin. b. One squamous cell carcinoma of the skin not worse than Stage T1 that has been successfully treated, with no signs of recurrence or metastases for at least the past 2 years before study treatment initiation. c. Actinic keratosis. d. Squamous cell carcinoma in situ of the skin successfully treated >6 months before study treatment initiation. e. Localized carcinoma in situ of the cervix treated and considered cured.
- Participants with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- Participant with fibromyalgia, osteoarthritis symptoms, or any other condition that in the investigator’s opinion may potentially interfere with efficacy assessments.
- Participants with primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants.
- Participants who currently use or plan to use one or more prohibited treatments specified in this protocol (Section 6.10.2). Prohibited treatments and washout periods are described in Table 7, along with the permitted medications.
- Participants who have received a live (including attenuated) vaccination within 8 weeks before the Baseline Visit or have a firm medical indication to receive a live vaccination during the study and up to 8 weeks after the last dose of study treatment. Examples of restricted vaccinations include, but are not limited to: a. Zoster vaccine live (Zostavax). b. Measles-mumps-rubella or measles-mumps-rubella-varicella. c. Monovalent live attenuated influenza A (intranasal). d. Oral polio. e. Rotavirus. f. Seasonal trivalent live attenuated influenza (intranasal). g. Smallpox. h. Oral typhoid. i. Varicella (chicken pox). j. Yellow fever.
- Participants with total ankylosis of the spine.
- Participants who are enrolled in another interventional investigational study for a device or drug, or that have been enrolled in the last 28 days before the initiation of study treatment or within 5 half-lives of the investigational study drug before the initiation of study treatment, whichever is longer.
- Participants with clinically significant laboratory abnormalities at the Screening, including any of the following: a. AST, ALT, or ALP >3×ULN. b. Serum direct bilirubin >1.5×ULN (in the absence of known Gilbert syndrome). c. White blood cell count <3.0×109/L. d. Absolute neutrophil count <1.5×109/L. e. Absolute lymphocyte count <0.7×109/L. f. Platelet count <100×109/L. g. Hemoglobin <85 g/L. h. Creatinine clearance <30 mL/min (by Cockcroft Gault formula).
- Participants with any other laboratory abnormality which, in the opinion of the investigator, might compromise participant’s safety, prevent the participant from completing the study or would interfere with the interpretation of the study results.
- Participants with severe cardiovascular comorbidities including history of myocardial infarction, unstable angina pectoris, stroke, heart failure (New York Association [NYHA classification III or IV]), or uncontrolled hypertension (characterized by 2 BP measurements separated at least 15 minutes with systolic BP >160 mmHg or diastolic BP >100 mmHg).
- Participants who have had major surgery (e.g., joint surgery, hip replacement) within 6 months before the initiation of study treatment or are planning to have major surgery during the study.
- Participants who have a history of chronic alcohol or drug abuse in the past year before the Screening.
- Participants with any other clinically significant medical conditions or any other reasons, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study treatment, or would put the participant at risk.
- Participants who are an employee or a direct relative of an employee of the sponsor, a study center, or a third-party organization involved in the study.
- For participants with biopsy samples taken: history of clinically relevant coagulation disorders or medication that, after discussion between the investigator and medical monitor, are considered to pose a significant risk of bleeding during biopsy, or known hypersensitivity against local anesthetics.
- Participants who currently, or in their history, have an established diagnosis of arthritis mutilans a. Note: participants with any other PsA clinical subtype (e.g., symmetrical polyarthritis, asymmetrical oligoarthritis, distal interphalangeal arthritis, and arthritis with axial involvement) are eligible for the study.
- Diagnosis of rheumatoid arthritis, systemic or cutaneous lupus erythematosus, reactive arthritis, enteropathic arthritis, or sarcoidosis
- Participants with erythrodermic, guttate, or pustular form of psoriasis or drug-induced psoriasis.
- Participants who have ever received more than two compounds of either bDMARDs (TNF inhibitors, IL-12/23 p40, IL-23 p19 inhibitors, or abatacept) or tsDMARDs (e.g., JAKi, tyrosine kinase 2 [TYK2] inhibitors) for PsA, psoriasis, or axSpA, whether investigational or approved, in any successive combination and order of use.
- Participants who are unsuitable for IL-17A/IL-17F therapy according to the investigator’s discretion.
- Participants defined as primary non-responders on anti-IL-17A therapy, according to the investigator’s judgment or are unsuitable for anti-IL-17A therapy for any other reason according to the investigator’s discretion. Washout period is described in Table 7 (Section 6.10.2).
- Participants with previous exposure to anti-IL-17RA (e.g., brodalumab), and/or anti-IL-17A/F therapies (e.g., bimekizumab), including sonelokimab.
- Participants with any other active rheumatic and/or inflammatory disease or condition that may, in the opinion of the investigator, interfere with the assessment of PsA or axSpA.
- Participants with current severe or uncontrolled disease(s) or with underlying conditions that put(s) the participant at increased risk, including any medical or psychiatric condition that, in the investigator’s opinion, potentially places the participant at unacceptable risk or would preclude the participant from adhering to the protocol or completing the study per protocol.
- Participant with evidence of acute ocular inflammation, including active anterior uveitis (i.e., acute episode), within the last 4 weeks before the Baseline Visit.
- Participants with a confirmed or suspected diagnosis of IBD (e.g., ulcerative colitis or Crohn’s disease), either in medical history or currently present. a. Note: participants with functional gastrointestinal disorders (e.g., Irritable Bowel Syndrome) can be considered eligible for enrolment if IBD has been excluded and documented (e.g., formal clinical criteria, endoscopy, fecal calprotectin stool test).
- Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the initiation of study treatment.
- Participants with an active infection or history of infections including any of the following: a. Any infection (exception: common cold) requiring systemic anti-infective treatment within 14 days before initiation of study treatment. b. Serious infection, defined as requiring hospitalization or intravenous antiinfectives, within 2 months before initiation of study treatment. c. Candida infection requiring systemic therapy for ≥7 days in the last 12 months before initiation of study treatment. d. Any history of esophageal or systemic candidiasis. e. Current active candidiasis or Candida infection within the last 1 month before Baseline Visit. f. History of opportunistic infections caused by uncommon pathogens (e.g., Pneumocystis jirovecii, Blastomyces, Aspergillus, Cryptococcosis), or severe infections caused by common pathogens (e.g., cytomegalovirus, severe herpes zoster [i.e., multidermatomal herpes zoster, herpes zoster with organ involvement, ophthalmic herpes, or recurrent herpes zoster, defined as 2 episodes within 2 years before the Baseline Visit]). g. History of other opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause study participation to be detrimental to the participant.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Germany | Recruiting | 28 Mar 2025 | 30 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
68Ga-FAPI-46 | Other | SOLUTION FOR INJECTION | INJECTION | 200 | 2 | PRD11952450 |
Sonelokimab | Test | INJECTION | SUBCUTANEOUS INJECTION | 60 | 8 | PRD10271601 |