Effects of IL-23 inhibition in patients with very early axial spondyloarthritis – evidence for a true disease modification?

Prior treatment

• Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device)
• Patients with any contraindication to perform MRI or failure to perform MRI prior to baseline
• Positive interferon gamma release assay (IGRA) test at screening and/or abnormal chest x-ray (within 3 months prior to screening) suggestive for past or present tuberculosis. Patients with positive IGRA test but with negative x-ray and without clinical symptoms for tuberculosis may participate in the study after initiation of standard prophylactic antimycobacterial treatment
• Patients who have received a live vaccination within the last 8 weeks prior to baseline

Other illness

• Current malignancy or history of malignancy, although patients with less than 3 completely excised basal cell carcinomas or with one successfully operated cervical carcinoma in situ more than 5 years prior to screening may be included
• Patients with severe, progressive, and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, or neurologic disease or with a history of such disease
• Patients with clinically important active infections
• Chronic infection such as hepatitis B or C infection
• Immunocompromised patients or history of HIV infection
• Patients have a history of chronic alcohol or drug abuse
• Patients have a medical or psychiatric condition that, in the opinion of the investigator, would jeopardize or impair the ability to participate in this study
• Patients have a known hypersensitivity to the active substance (risankizumab) or to any of the excipients
• Patients must not have a secondary, non-inflammatory condition (e.g., osteoarthritis or fibromyalgia) that, in the opinion of the investigator, is sufficiently prominent to interfere with the evaluation of the effect of study drug on the primary diagnosis of axial SpA

Lab values

• Patients with any other condition, including the presence of laboratory abnormalities, which, in the judgment of the investigator, makes the subject unsuitable for participation in the study

Other

• Female patients with positive urine pregnancy test
• Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)
• Patients who are unable to speak and read German
• Have participated in this study before
• Patients must not have any other inflammatory arthritis, e.g., RA, systemic lupus erythematosus, sarcoidosis, or others
• Female patients who are breastfeeding, pregnant, or plan to become pregnant during the study

• A written informed consent form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been signed by the patients.
• Baseline-MRI must be available, and patients must agree to the planned MRI procedures
• Patients are considered reliable and are able to adhere to the protocol, comply with the schedule of visits, or take medications as judged by the investigator
• Patients are at least 18 years and not older than 40 years of age at the time of the screening visit
• Patients must have a documented diagnosis of very early axSpA with symptom duration of at least 3 months but below 2 years
• Patients must have active disease, at the screening and the baseline visit, defined by: - BASDAI score ≥ 4/10 and spinal pain ≥ 4/10 on an NRS. - Either elevated CRP level and/or current evidence of sacroiliitis on an MRI scan within 3 months prior to baseline
• Patients must be HLA-B27 positive at screening
• Patients must have demonstrated intolerance or inadequate response to at least 2 NSAIDs. Inadequate response to an NSAID is defined as a lack of response to at least 14 days of continuous NSAID therapy with the highest tolerated dose of the NSAID administered
• Patients must not have received pre-treatment b- and ts-DMARDs prior to screening ('bDMARD naïve')
• Female patients of childbearing potential (FCBP) must use an effective method of contraception (including oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier, and spermicide or contraceptive methods considered at least as safe for contraception). Exclusive abstinence would not be an acceptable method. FCBP must agree to use effective contraception during the study and for at least 5 months (according to the Summary of Product Characteristics) after the last dose of study treatment. Male subjects who are not documented to be sterile must agree to ensure that they or their partner(s) use adequate contraception for the duration of the study.