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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04711902
Eligibility Criteria:
Inclusion Criteria:
* Participant must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
* Chinese male or non-pregnant, non-lactating Chinese female participants at least 18 years of age.
* Diagnosis of PsA classified by Classification of Psoriatic Arthritis (CASPAR) criteria and with symptoms for at least 6 months with moderate to severe Psoriatic arthritis (PsA).
* Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
* Participants on Methotrexate (MTX) must be on folic acid supplementation at randomization.
* Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed.
Exclusion Criteria:
* Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
* Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
* Previous exposure to secukinumab or other biologic drug directly targeting interleukin- 17 (IL-17) or IL-17 receptor
* Participants who have ever received biologic immunomodulating agents except for those targeting Tumor necrosis factor alpha (TNFα).
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception during the entire study (during the entire study).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04711902
Study Brief:
Protocol Section:
NCT04711902