High Dose Risankizumab for Psoriasis (KNOCKOUT)

Oregon Medical Research Center

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: risankizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05283135

B20-433

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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