BridgeMD
A Phase 2 open-label imaging study to explore the effects of sonelokimab in patients with active axial spondyloarthritis
EU CTIS ID: 2024-513498-36-00
What this study is testing
To assess the reduction of inflammatory activity as measured by 18NaF maximum signal tracer uptake on positron emission tomography (PET) scan (SUVmax).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be ≥18 years of age at the time of signing the informed consent.
- 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: Regulatory, Ethical, and Study Oversight Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participant has nr-axSpA diagnosis with all of the following criteria: 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 4 weeks prior to Screening) or positive 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 SI joints and according to the ASAS classification criteria with documented radiologic evidence (observed within 1 year prior to Screening).
- 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.
- Presence of signs of active disease on MRI of the SI joints or spine not older than 4 weeks prior to screening.
- Presence of signs of active disease as defined by positive NaF-PET.
You likely can't join if
- Participants with a known hypersensitivity to sonelokimab or any of its excipients; participants with a known hypersensitivity to 18F-fluoride sodium 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.
See the full eligibility criteria
Who can join
- Participants must be ≥18 years of age at the time of signing the informed consent.
- 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: Regulatory, Ethical, and Study Oversight Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participant has nr-axSpA diagnosis with all of the following criteria: 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 4 weeks prior to Screening) or positive 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 SI joints and according to the ASAS classification criteria with documented radiologic evidence (observed within 1 year prior to Screening).
- 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.
- Presence of signs of active disease on MRI of the SI joints or spine not older than 4 weeks prior to screening.
- Presence of signs of active disease as defined by positive NaF-PET.
- Participants are ideally naïve to bDMARDs or tsDMARDs, or may have received: a. up to 2 prior TNFi b. Up to 1 IL-12/23p40 or up to 1 IL-23p19 inhibitors c. Up to 1 JAKi
- Sacroiliac joint radiographs, taken from routine visit, must be available within 12 months prior to Screening, to determine the presence of radiographic changes in the SI joints and that the patients fulfill the ASAS classification criteria.
- Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or, if 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 pregnancy test at Screening and a negative urine test at Week 0/Day 1 before initiation 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 8 weeks after the last dose of study treatment, unless surgically sterile.
What rules you out
- Participants with a known hypersensitivity to sonelokimab or any of its excipients; participants with a known hypersensitivity to 18F-fluoride sodium 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.
- 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 who are unsuitable for IL-17A/IL-17F therapy according to the investigator’s discretion.
- Participants with total ankylosis of the spine.
- Participants who are or were enrolled in another interventional investigational study for a device or drug within the last 6 months or within 5 half-lives of the investigational before Screening, whichever is longer.
- Participants with the following laboratory abnormalities at Screening: 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 <60 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 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 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 or known hypersensitivity against local anesthetics.
- Participants defined as primary non-responder 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.
- Participants with previous exposure to anti-IL-17RA (e.g., brodalumab), and/or anti-IL- 17A/F therapies (e.g., bimekizumab), including sonelokimab.
- Diagnosis of rheumatic inflammatory diseases or conditions other than axSpA, e.g., rheumatoid arthritis, PsA, sarcoidosis, systemic lupus erythematosus, enteropathic or reactive arthritis.
- 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 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.
- Participants with a confirmed or suspected diagnosis of IBD (e.g., ulcerative colitis or Crohn’s disease), either in medical history or currently present. 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 with evidence of acute ocular inflammation, including active anterior uveitis (i.e., acute episode), within the last 4 weeks before the Baseline Visit.
- 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. Previous esophageal or systemic candidiasis. e. Current active candidiasis or Candida infection within the last 3 months before the initiation of study treatment. f. History of opportunistic infections caused by uncommon pathogens (eg, Pneumocystis jirovecii, Blastomyces, Aspergillus, Cryptococcosis), or severe infections caused by common pathogens (eg, cytomegalovirus, severe herpes zoster [ie, 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.