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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06333860




Registration number
NCT06333860
Ethics application status
Date submitted
21/03/2024
Date registered
27/03/2024
Date last updated
25/06/2024

Titles & IDs
Public title
A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body)
Scientific title
A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
Secondary ID [1] 0 0
M24-541
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Risankizumab
Treatment: Drugs - Deucravacitinib

Experimental: Period A: Arm 1 Risankizumab Dose A - Participants will be centrally randomized at the Baseline (Day 1) visit to receive Risankizumab as a single SC injection

Experimental: Period A: Arm 2 Deucravacitinib Dose A - Participants will be centrally randomized at the Baseline (Day 1) visit to receive Deucravacitinib orally once per day until the day prior to Week 16

Experimental: Period B: Arm 2a Risankizumab Dose A (Continued) - Participants initially randomized to risankizumab (Arm 1) will continue to receive risankizumab as a single SC injection at Weeks 16, 28, and 40

Experimental: Period B: Arm 2b Deucravacitinib Dose A - Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Deucravacitinib orally once per day up to Week 52

Experimental: Period B: Arm 2a Risankizumab Dose A - Participants initially randomized to Deucravacitinib (Arm 2) will be re-randomized at the Week 16 visit to receive Risankizumab as a single SC injection at Weeks 16, 20, 32, and 44


Treatment: Drugs: Risankizumab
Solution for Subcutaneous (SC) injection

Treatment: Drugs: Deucravacitinib
Oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90)
Timepoint [1] 0 0
At Week 16
Primary outcome [2] 0 0
Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline
Timepoint [2] 0 0
Baseline, Week 16
Primary outcome [3] 0 0
Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR).
Timepoint [3] 0 0
At Week 52
Secondary outcome [1] 0 0
Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100)
Timepoint [1] 0 0
At Week 16
Secondary outcome [2] 0 0
Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline
Timepoint [2] 0 0
Baseline. Week 16
Secondary outcome [3] 0 0
Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population
Timepoint [3] 0 0
At Week 52
Secondary outcome [4] 0 0
Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population.
Timepoint [4] 0 0
At Week 52

Eligibility
Key inclusion criteria
* Participant with a diagnosis of chronic plaque psoriasis (PsO) with or without psoriatic arthritis, for at least 6 months prior to Baseline.
* Stable moderate chronic plaque psoriasis at both Screening and Baseline as defined as:

* Body Surface Area (BSA) = 10% and = 15%,
* Psoriasis Area and Severity Index (PASI) = 12, and
* Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).
* Participant must be a candidate for systemic therapy as assessed by the investigator
* Psoriasis inadequately controlled by topicals, phototherapy and/or systemic treatments (including, but not limited to, methotrexate, apremilast, cyclosporine A, corticosteroids, and/or cyclophosphamide)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
* Participants with a history of current drug-induced PsO or a drug-induced exacerbation of preexisting PsO.
* Participants with a history of active ongoing inflammatory skin diseases other than PsO (with or without PsA) that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
* Participants with a history of severe renal insufficiency defined as creatinine clearance < 30 mL/min and/or requiring hemodialysis or peritoneal dialysis.
* Participantswith a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* Participants with a history of an allergic reaction or significant sensitivity to constituents of the study drugs (and its excipients) and/or other products in the same class.
* Participants who have had major surgery performed within 12 weeks prior to randomization or planned during the conduct of the study (e.g., hip replacement, aneurysm removal, stomach ligation).
* Participants with evidence of:

Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as:

* HBV: Hepatitis B surface antigen (HBs Ag) positive (+) test or detected sensitivity on the HBV DNA PCR qualitative test for subjects who are hepatitis B core antibody (HBc Ab) positive (+) (and for hepatitis B surface antibody [HBs Ab] positive [+] participants where mandated by local requirements).
* HCV: HCV RNA detectable in any participant with anti-HCV antibody (HCV Ab).
* Human immunodeficiency virus (HIV), defined as confirmed positive anti-HIV Ab test and considered to have unstable disease (Unless meeting criteria for stable disease) Participants with HIV with no history of AIDS-defining conditions AND stable disease for at least 6 months prior to screening can be enrolled. Criteria for stable disease is achieved if all below criteria are met. Documentation of "stable disease" can be done at the Screening visit or by documentation of labs performed within 1 month of the Randomization visit, in addition to the subject's medical history.
* On stable antiretroviral therapy;
* Viral load (HIV RNA) below the lower limit of quantification by a validated and approved plasma HIV-1 RNA quantitative assay;
* CD4+ T cell count = 500 cells/µL.

- Participants with any of the following medical diseases or disorders:
* Recent (within past 6 months) cerebrovascular accident or myocardial infarction;
* History of an organ transplant which requires continued immunosuppression;
* Active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
* Prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent and randomization, or major depression or suicidal ideation or attempt requiring hospitalization within the last 3 years prior to signing the informed consent.
* Hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

- Participants who received within 30 days prior to Baseline any:
* Other systemic immunomodulating treatments (including, but not limited to:

e.g., methotrexate, apremilast, cyclosporine A, corticosteroids, cyclophosphamide, tofacitinib [Xeljanz®]);
* Other systemic PsO treatments (e.g., retinoids, fumarates, any other drug known to possibly benefit PsO);
* Photochemotherapy (e.g., PUVA), phototherapy (e.g., UVB) or prolonged exposure or use of tanning booths or ultraviolet light sources.

* Participants who received within 14 days prior to Baseline any topical treatment for PsO or any other skin condition (including, but not limited to: e.g., corticosteroids, vitamin D analogues, vitamin A analogues, pimecrolimus, retinoids, salicyl vaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, or anthralin).
* Participants who have been treated with any strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, St. John's Wort) within 30 days or 5 half-lives of start of treatment with deucravacitinib.
* Participants who received any live viral or bacterial vaccine within 4 weeks prior to the first dose of study drug, or expect the need for live vaccination during study participation including at least 147 days (21 weeks or as guided by the local risankizumab label [if approved], whichever is longer) after the last dose of risankizumab or at least 30 days after the last dose of deucravacitinib.
* Participants who have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
336
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Skin Hospital - Sydney /ID# 263634 - Sydney
Recruitment hospital [2] 0 0
Sinclair Dermatology - Melbourne /ID# 262997 - East Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Puerto Rico
State/province [17] 0 0
Rio Piedras
Country [18] 0 0
Puerto Rico
State/province [18] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.

This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participants

Participants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT06333860
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06333860