High Dose Risankizumab for Psoriasis

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study that explores whether higher initial doses of risankizumab (300 mg and 600 mg, 2 times and 4 times the standard initial doses for plaque psoriasis) can more effectively target resident memory T cells, a type of immune cell within psoriatic lesions, and whether this results in higher levels of completely clear skin and for longer periods of time following withdrawal of drug. It is believed that resident memory T cells in psoriatic skin contribute to the persistence of psoriasis. It is believed that if the study drug can more effectively eliminate these cells, better clearance of psoriasis may be achieved (when compared to standard initial doses of study drug).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Medical Research Center
• Collaborator: AbbVie

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