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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT05283135
Eligibility Criteria:
Inclusion Criteria:
* Subject has provided written consent
* Subject has the ability to comply with all study visits and procedures
* Subject is at least 18 years of age
* Subject has chronic stable plaque psoriasis for at least 6 months and with a severity of BSA greater than or equal to 10 and PASI greater than or equal to 12
* Female subjects of child-bearing potential must have a negative urine test at screening and baseline. Female subjects must be either postmenopausal, or permanently surgically sterile, or for women of child-bearing potential practicing at least one form of birth control
Exclusion Criteria:
* Breastfeeding or pregnant women, or women who plan to become pregnant during study period
* Participation in any other clinical trial
* Active infection with HIV, hepatitis B virus, or hepatitis C virus
* Active infection with tuberculosis or untreated latent tuberculosis
* History of known active cancer, other than non-melanoma skin cancer or cervical carcinoma in situ, in the past 3 years
* History of drug or alcohol abuse in the past 6 months, as per investigator's assessment
* History of suicidal ideation or attempts in the past 6 months
* Presence of any concurrent illness, which in the opinion of the investigator, would place the patient at unnecessary safety risk during the trial or interfere with completion of the trial
* Treatment with topical medications for psoriasis in the past 2 weeks
* Treatment with oral medications for psoriasis in the past 4 weeks
* Phototherapy for psoriasis in the past 4 weeks
* Any prior treatment with Risankizumab
* Treatment with biologic medications for psoriasis (other than Risankizumab) in the past 4 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05283135
Study Brief:
Protocol Section:
NCT05283135