Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT07047703
Eligibility Criteria:
Inclusion Criteria:
Healthy Volunteers
* Healthy male and female subjects aged 18-55 years inclusive, at the Screening visit
* Participant must provide written informed consent to participate in the study
* Participant must be able and willing to comply with the requirements of the protocol (including dietary restrictions and exclusion of grapefruit juice)
* Male participants (and their female partners) / female participants must be willing to adhere to contraception requirements as detailed in the protocol
* Non-smokers or ex-smokers who have not smoked within the previous 6 months, as determined at the Screening visit
* Participant with a Body Mass Index (BMI) of 19-30. Body Mass Index = Body weight (kg) / \[Height (m)\]2
AxSpA Participants
* Male or female, 18-65 years of age
* Participants diagnosed with Axial Spondyloarthritis, also fulfilling ASAS classification criteria including:
1. HLA-B27 +ve (local testing)
2. Objective evidence of inflammation at screening, specifically active sacroiliac joint inflammation on MRI fulfilling the ASAS MRI criteria (MRI+), assessed by the Principal Investigator or appropriately trained delegate, and/or elevated C-reactive protein (CRP+) ≥5.0mg/L.
* Symptom duration of ≥3 months
* Age at onset of active disease of \<40 years
* A score of ≥ 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.
* At least one of the following:
1. Current treatment with a NSAID, at a sufficient dose and following an appropriate dosing duration per local clinical guidelines, with inadequate clinical response OR
2. Intolerance to ≥1 NSAID or contraindication(s) to NSAIDs
* Participants may have received 1 prior/(Australia only) 2 prior b/ts DMARD and discontinued due to intolerance or inadequate efficacy.
* Participants who have received 1/(Australia only) 2 prior treatments are required to undergo a washout at minimum:
1. Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.
2. JAK inhibitor DMARDs 2 weeks prior to Day 1
Exclusion Criteria:
Healthy Volunteers
* History or presence of any clinically significant findings in medical history, physical examination, vital signs and/or laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the study
* Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
* Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and/or hepatitis B or C infection, as determined at the Screening visit
AxSpA Participants
* Participants who have received \>1/(Australia only) \>2 biologic or JAK inhibitor DMARD or are receiving any other disease-modifying antirheumatic drugs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications.
* Inadequate Haematologic function, defined as:
1. Haemoglobin \<10 g/dL.
2. Absolute white blood cell count \<3.0 x 109 /L (\<3000 mm3)
3. Absolute neutrophil count \<1.2 x 109 /L (\<1200 mm3)
4. Absolute lymphocyte count \<1.0 x 109 /L (\<1000 mm3)
5. Platelet count \<100 x 109 /L (\<100.000 mm3)
* Inadequate liver function, defined as; total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal at screening visit. For subjects with Gilberts syndrome, upper limit of normal for total bilirubin will be 2.9mg/dl
* History of any other autoimmune rheumatic disease (e.g., psoriatic arthropathy, systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymositis) or known diagnosis of fibromyalgia
* Participants with a previous history of or currently stable psoriasis are eligible
* Active or symptomatic inflammatory bowel disease (IBD). Participants with a history of IBD are allowed to participate
* Presence of active anterior uveitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07047703
Study Brief:
Protocol Section:
NCT07047703