Status:
COMPLETED
High Dose Risankizumab for Psoriasis
Lead Sponsor:
Oregon Medical Research Center
Collaborating Sponsors:
AbbVie
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This pilot study explores higher than standard doses of risankizumab for plaque psoriasis, to see effects on resident memory T cells and skin clearance.
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05283135
Start Date
March 1 2022
End Date
July 10 2024
Last Update
October 24 2025
Active Locations (1)
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1
Oregon Medical Research Center
Portland, Oregon, United States, 97201