Risankizumab for Axial spondyloarthritis

Inclusion criteria

• {"criterion_text":"- A written informed consent form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been signed by the patients."}
• {"criterion_text":"- Baseline-MRI must be available, and patients must agree to the planned MRI procedures"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients are at least 18 years and not older than 40 years of age at the time of the screening visit"}
• {"criterion_text":"- Patients must have a documented diagnosis of very early axSpA with symptom duration of at least 3 months but below 2 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients must be HLA-B27 positive at screening"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients must not have received pre-treatment b- and ts-DMARDs prior to screening ('bDMARD naïve')"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients with severe, progressive, and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, or neurologic disease or with a history of such disease"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients with any contraindication to perform MRI or failure to perform MRI prior to baseline"}
• {"criterion_text":"- Patients with clinically important active infections"}
• {"criterion_text":"- Female patients with positive urine pregnancy test"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Chronic infection such as hepatitis B or C infection"}
• {"criterion_text":"- Immunocompromised patients or history of HIV infection"}
• {"criterion_text":"- Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)"}
• {"criterion_text":"- Patients who are unable to speak and read German"}
• {"criterion_text":"- Have participated in this study before"}
• {"criterion_text":"- Patients have a history of chronic alcohol or drug abuse"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients have a known hypersensitivity to the active substance (risankizumab) or to any of the excipients"}
• {"criterion_text":"- Patients must not have any other inflammatory arthritis, e.g., RA, systemic lupus erythematosus, sarcoidosis, or others"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Female patients who are breastfeeding, pregnant, or plan to become pregnant during the study"}
• {"criterion_text":"- Patients who have received a live vaccination within the last 8 weeks prior to baseline"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients in low disease activity, defined as ASDAS status of <2.1 after 28 weeks of treatment (primary endpoint), assessed 4 weeks after the last injection (week 32 of the study)","definition_or_measurement_approach":"ASDAS status <2.1 assessed after 28 weeks of treatment; assessment performed 4 weeks after last injection (week 32). Primary endpoint is the proportion of patients meeting ASDAS <2.1 at that assessment."}
• {"endpoint_text":"- Proportion of patients who stay in low disease activity for at least 6 months after treatment withdrawal","definition_or_measurement_approach":"Proportion of patients who maintain low disease activity for at least six months following treatment withdrawal (sustained low disease activity over a 6-month post-withdrawal period)."}

Secondary endpoints

• {"endpoint_text":"- Improvement of patient´s global assessment after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)","definition_or_measurement_approach":"Change in patient global assessment measured after 28 weeks of treatment; assessed 4 weeks after last injection (week 32)."}
• {"endpoint_text":"- Proportion of patients in inactive disease, defined as ASDAS status of <1.3 at week 32 and at week 56","definition_or_measurement_approach":"Proportion achieving ASDAS <1.3 at specified time points (week 32 and week 56)."}
• {"endpoint_text":"- Improvement in MRI-related inflammatory lesions (quantified by Berlin score for spine and sacroiliac joints) at week 32 and week 56","definition_or_measurement_approach":"MRI inflammatory lesions quantified using the Berlin score for spine and sacroiliac joints at week 32 and week 56; change from baseline assessed."}
• {"endpoint_text":"- Proportion of patients with good overall clinical function (ASAS Health Index (HI) ≤ 5) at week 32 and at week 56","definition_or_measurement_approach":"Proportion of patients with ASAS HI ≤5 at week 32 and week 56."}
• {"endpoint_text":"- Proportion of patients with a major clinical response, defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)","definition_or_measurement_approach":"Proportion achieving BASDAI 50 (50% improvement from baseline) after 28 weeks; assessed 4 weeks after last injection (week 32)."}
• {"endpoint_text":"- Change from baseline in BASMI and BASFI after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)","definition_or_measurement_approach":"Change from baseline in BASMI and BASFI measured after 28 weeks of treatment; assessed 4 weeks after last injection (week 32)."}

Germany

Earliest CTIS Part Ii Submission Date

09-08-2024

Latest Decision Or Authorization Date

16-08-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Contract research organisations

Name

ALGORA Gesellschaft fuer Medizinstatistik und Vertriebssysteme mbH

Responsibilities

sponsorDuties codes: 1,10,11,12,6,7,8; contact karl.fehnle@algora.de

Third parties

• {"country":"Germany","full_name":"ALGORA Gesellschaft fuer Medizinstatistik und Vertriebssysteme mbH","duties_or_roles":"sponsorDuties codes: 1,10,11,12,6,7,8; contact karl.fehnle@algora.de","organisation_type":"Pharmaceutical company"}
• {"country":"","full_name":"AbbVie","duties_or_roles":"Monetary support (sourceOfMonetarySupport)","organisation_type":""}