Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate Plaque Psoriasis who are Candidates for Systemic Therapy

A Phase 3b Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005512-21-DE

Enrollment

330

Registered

2021-05-07

Start date

2021-07-06

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate plaque psoriasis. MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: Risankizumab Solution for Injection 150 mg/1 mL Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Candidates for systemic therapy with moderate psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as: - Body Surface Area (BSA) >= 10% and = 12%; and - Static Physician Global Assessment = 3 (moderate) based on a 5-point scale (0 to 4) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 285 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: 1. Participant has other form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO). 2. History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis. 3. History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema). 4. Prior exposure to risankizumab or apremilast.

Design outcomes

Primary

Measure	Time frame
Main Objective: • The primary efficacy objective in Period A is to demonstrate a higher rate of 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 apremilast based on Intent to Treat (ITT) Population in Period A (ITT_A), which consists of all randomized subjects. • The primary efficacy objective in Period B is to demonstrate a higher rate of PASI 90 after switching the treatment at Week 16 from APR to RZB for 36 weeks (APR/RZB) when compared to continuing with APR (APR/APR) based on the Intent to Treat Population in Period B for Week 16 APR-PASI75NRs (ITT_B_NR), which consists of subjects who are randomized to APR at Baseline, fail to achieve PASI 75 at Week 16, and are re randomized. ;Secondary Objective: • The key secondary efficacy objective in Period A is to demonstrate higher efficacy of treatment with RZB when compared to APR with respect to the Achievement of PASI 75 at Week 16, among subjects in the ITT_A Population. • The key secondary efficacy objectives in Period B are to demonstrate higher efficacy of treatment with APR/RZB when compared to APR/APR among APR-PASI75NRs, with respect to a) the Achievement of PASI 75 at Week 52, among subjects in the ITT_B_NR Population and b) the Achievement of sPGA 0 or 1 with at least 2-grade improvement from Baseline at Week 52, among subjects in the ITT_B_NR Population. ;Primary end point(s): Co-Primary Endpoints in Period A (baseline to Week 16): • Achievement of = 90% reduction from Baseline in PASI (PASI 90) at Week 16, among subjects in the Intent to Treat Population in Period A (ITT_A; defined as all subjects who are randomized at Baseline). • Achievement of static Physicians Global Assessment (sPGA) 0 or 1 with at least 2-grade improvement from Baseline at Week 16, among subjects in the ITT_A Population. Primary Endpoint in Period B (Week 16 to Week 52): • Achievement of	—

Measure

Time frame

Main Objective: • The primary efficacy objective in Period A is to demonstrate a higher rate of 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 apremilast based on Intent to Treat (ITT) Population in Period A (ITT_A), which consists of all randomized subjects. • The primary efficacy objective in Period B is to demonstrate a higher rate of PASI 90 after switching the treatment at Week 16 from APR to RZB for 36 weeks (APR/RZB) when compared to continuing with APR (APR/APR) based on the Intent to Treat Population in Period B for Week 16 APR-PASI75NRs (ITT_B_NR), which consists of subjects who are randomized to APR at Baseline, fail to achieve PASI 75 at Week 16, and are re randomized. ;Secondary Objective: • The key secondary efficacy objective in Period A is to demonstrate higher efficacy of treatment with RZB when compared to APR with respect to the Achievement of PASI 75 at Week 16, among subjects in the ITT_A Population. • The key secondary efficacy objectives in Period B are to demonstrate higher efficacy of treatment with APR/RZB when compared to APR/APR among APR-PASI75NRs, with respect to a) the Achievement of PASI 75 at Week 52, among subjects in the ITT_B_NR Population and b) the Achievement of sPGA 0 or 1 with at least 2-grade improvement from Baseline at Week 52, among subjects in the ITT_B_NR Population. ;Primary end point(s): Co-Primary Endpoints in Period A (baseline to Week 16): • Achievement of = 90% reduction from Baseline in PASI (PASI 90) at Week 16, among subjects in the Intent to Treat Population in Period A (ITT_A; defined as all subjects who are randomized at Baseline). • Achievement of static Physicians Global Assessment (sPGA) 0 or 1 with at least 2-grade improvement from Baseline at Week 16, among subjects in the ITT_A Population. Primary Endpoint in Period B (Week 16 to Week 52): • Achievement of

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Secondary

Measure	Time frame
Secondary end point(s): Ranked Secondary Endpoint in Period A: • Achievement of PASI 75 at Week 16, among subjects in the ITT_A Population Ranked Secondary Endpoints in Period B: • Achievement of PASI 75 at Week 52, among subjects in the ITT_B_NR Population • Achievement of sPGA 0 or 1 with at least 2-grade improvement from Baseline at Week 52, among subjects in the ITT_B_NR Population;Timepoint(s) of evaluation of this end point: Period A secondary endpoint will be evaluated at Week 16; Period B secondary endpoints will be evaluated at Week 52.	—

Measure

Time frame

Secondary end point(s): Ranked Secondary Endpoint in Period A: • Achievement of PASI 75 at Week 16, among subjects in the ITT_A Population Ranked Secondary Endpoints in Period B: • Achievement of PASI 75 at Week 52, among subjects in the ITT_B_NR Population • Achievement of sPGA 0 or 1 with at least 2-grade improvement from Baseline at Week 52, among subjects in the ITT_B_NR Population;Timepoint(s) of evaluation of this end point: Period A secondary endpoint will be evaluated at Week 16; Period B secondary endpoints will be evaluated at Week 52.

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Countries

Canada, Germany, Israel, Poland, United States

Contacts

Public ContactGlobal Clinical Trials Helpdesk

AbbVie Ltd.

global-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026