Rapid pain control in Ixekizumab targeted axial spondyloarthritis

Prior treatment

• prior exposure to bDMARDs
• treatment with Glucocorticoids of more than 10 mg/day
• previous Ixekizumab treatment within 4 weeks (or 5 half-lives, whichever is longer) prior to enrolment
• any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon Tb-test. (if presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrolment) or history of recurrent infections
• requirement for immunization with live vaccine during trial participation or within the four weeks prior to screening

Other illness

• history of or presence of inflammatory bowel disease including Crohn’s disease and ulcerative colitis
• Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
• Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C)
• any other autoimmune or inflammatory disease (e.g. but not limited to RA, SLE, SSc, MCTD, Behcet disease, vasculitis, or autoimmune hepatitis)
• history of venous thrombosis or pulmonary embolism

Lab values

• Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
• any condition, including the presence of laboratory abnormalities, which would impact the safety of the subject or the interpretation of the trial results

Other

• any contraindication to perform MRI
• presence of fibromyalgia or other forms of widespread pain at the discretion of the investigator

• male or female subject aged ≥ 18 years at time of consent
• negative pregnancy test in women of childbearing potential (WOCBP) and willing to use at least 1 acceptable method of contraception throughout trial participation and for at least 10 weeks after treatment period
• understand and voluntarily sign informed consent form
• able to follow trial instructions and likely to attend and complete all required visits
• fulfils ASAS classification criteria for axSpA
• BASDAI > 4
• VAS pain (0 - 10) > 4
• indication for systemic treatment with bDMARDs (active disease, inadequate response to 2 NSAIDs at maximum tolerable dosage)
• current NSAID and/or analgesic therapy at stable dose for at least 2 weeks prior to screening and maintenance for the duration of the trial (if applicable)
• current Glucocorticoids treatment (≤ 10 mg/day) at stable dose for at least 4 weeks prior to screening and maintenance for the duration of the trial (if applicable)