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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT03849404
Eligibility Criteria:
Inclusion Criteria:
* Patient with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians Global Assessments (sPGA) ≥ 3 (moderate) at Screening and at BL.
* Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
* Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).
Exclusion Criteria:
* Patient has prior use of 2 or more biologics for treatment of PsO.
* Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), or other systemic autoimmune disorder inflammatory disease at the time of the Screening visit that would interfere with evaluations of the effect of the study drug on psoriasis.
* Patient has prior use of any of the following medications within specified time periods or will require use during the study:
1. Topical medications within 2 weeks of BL (Week 1).
2. PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
3. Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit.
4. Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
5. Any systemic steroid in the 4 weeks prior to BL.
Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03849404
Study Brief:
Protocol Section:
NCT03849404