Clinical trial NCT05283135: High Dose Risankizumab for Psoriasis
Official title: Decreasing Resident Memory T Cells While Increasing Clinical Durability: Higher Induction Doses of Risankizumab for Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
Risankizumab
Plaque
Skyrizi
Lead sponsor: Oregon Medical Research Center
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2022-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Primary Endpoint: The number and effector function of epidermal CD8+CD103+ Trm cells at Week 52 (compared to baseline) in psoriasis patients treated with 4X standard induction doses of risankizumab or 2X standard induction doses of risankizumab
timeFrame: Enrollment to Week 52
Secondary outcomes:
measure: Secondary Endpoint 1: The percentage of patients with Psoriasis Area and Severity Index (PASI) 100 at Weeks 28, 40, and 52 in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
timeFrame: Enrollment to Week 52
measure: Secondary Endpoint 2: Safety events over 52 weeks in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab
timeFrame: Enrollment to Week 52
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
Study officials:
affiliation: Oregon Medical Research Center
name: Benjamin D Ehst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EHZ, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018 Aug 25;392(10148):650-661. doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.
citation: Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, Tsai TF, Flack M, Gu Y, Williams DA, Thompson EHZ, Paul C. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3. Epub 2019 Jul 4.
citation: Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.