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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT03062618
Eligibility Criteria:
Inclusion Criteria:
Parts A and B
* Be 18 to 55 years old
* Be healthy with absence of clinically significant illness
* Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after
* Female participants must be postmenopausal or surgically sterile
* Have venous access sufficient for blood sampling
* Be a non-smoker
Part C
* Be 18 to 75 years old
* Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months
* Have at least 2 evaluable plaques located in at least 2 body regions
Exclusion Criteria:
Parts A and B
* Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections
* Hepatic or renal impairment
* Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
* Female participants who are pregnant or breast feeding
* Recent or ongoing infection
* History of alcohol or drug abuse
* Current or recent enrollment in a clinical trial judged not compatible with this study
Part C
* Have highly active psoriatic arthritis
* Have pustular, erythrodermic and/or guttate forms of psoriasis
* Have had a clinically-significant flare of psoriasis during the last 12 weeks
* Currently or recently taking certain prescribed therapies for psoriasis
* Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03062618
Study Brief:
Protocol Section:
NCT03062618