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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

11 Jul 2024 → 19 Mar 2026

Decision date (initial)

2024-07-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

The primary efficacy objective in Period A is to demonstrate superiority of risankizumab to deucravacitinib in achieving a) PASI 90 (defined as ≥ 90% reduction from Baseline in PASI) and b) sPGA 0 or 1 with at least 2-grade improvement from Baseline after 16 weeks of treatment with risankizumab when compared to deucravacitinib.

The primary efficacy objective in Period B is to demonstrate superiority of switching to risankizumab to continuing deucravacitinib in achieving PASI 90 at Week 52 among subjects who fail to achieve PASI 90 at 16 weeks of deucravacitinib treatment.

Secondary objectives 2

1. The key secondary efficacy objective in Period A is to demonstrate superior efficacy of treatment with risankizumab when compared to deucravacitinib with respect to the ranked secondary endpoints in Period A.
2. The key secondary efficacy objective in Period B is to demonstrate higher efficacy of treatment with deucravacitinib/risankizumab when compared to deucravacitinib/deucravacitinib among DEU-PASI90-NRs, with respect to the key secondary endpoints in a ranked order in Period B.

Conditions and MedDRA coding

Plaque Psoriasis

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Male or female adults (18 years or above) who are candidates for systemic therapy with a diagnosis of moderate chronic plaque PsO (with or without PsA) for at least 6 months prior to Baseline (Day 1), who have not previously been treated with biologics and at Screening and Baseline have been defined as: • BSA ≥ 10% and ≤ 15%; • PASI ≥ 12; and • sPGA = 3 (moderate) based on a 5-point scale (0 to 4)

Exclusion criteria 12

1. Employees of the sponsor and/or study sites and their family members may not be enrolled in this study.
2. Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug.
3. Subjects with any form of PsO other than chronic plaque PsO.
4. Subjects with a history of current drug-induced PsO or a drug-induced exacerbation of pre-existing PsO.
5. Subjects with a history of active ongoing inflammatory skin diseases other than PsO.
6. Subjects with a history of severe renal insufficiency defined as creatinine clearance < 30 mL/min and/or requiring hemodialysis or peritoneal dialysis.
7. Subjects with a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
8. Subjects 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.
9. Subjects who have had major surgery performed within 12 weeks prior to randomization or planned during the conduct of the study.
10. Subjects with evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Human immunodeficiency virus (HIV), Active TB, Active systemic infection/Clinically important infection during the last 2 weeks prior to Baseline visit as assessed by the investigator.
11. Subjects 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; prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent and randomization, hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
12. Subjects with concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Period A: Achievement of PASI 100 at Week 16
2. Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16
3. Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 90 at Week 52

Secondary endpoints 4

1. Period A: Achievement of PASI 100 at Week 16
2. Period A: Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 16
3. Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of PASI 100 at Week 52, among subjects
4. Period B, to be analyzed among subjects switching from deucravacitinib to risankizumab after failing to achieve PASI 90 at Week 16 (ITT_B_NR Population): Achievement of sPGA 0 with at least 2-grade improvement from Baseline at Week 52, among subjects

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 6

Locations

7 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 109 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications