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

NCT04908475 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: M20-3262020-005512-21
• Study Type: interventional
• Target: 352
• Locations: 5 countries
• Sites: 54

Brief Summary

Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored. Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally. The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Conditions

Psoriasis

Keywords

Psoriasis; Plaque Psoriasis; Risankizumab; ABBV-066; Skyrizi; Apremilast

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)

  The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.

  Week 16

• Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)

  The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).

  Week 16

• Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

  The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.

  Week 52

Secondary Outcomes (3)

• Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)

  Week 16

• Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

  Week 52

• Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

  Week 52

Study Arms (2)

Risankizumab

EXPERIMENTAL

Risankizumab 150 mg as a single subcutaneous (SC) injection at at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).

Drug: Risankizumab

Apremilast

EXPERIMENTAL

Participants receive apremilast 30 mg orally twice daily (BID) in Period A and re-randomized to receive either risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32 in Period B or apremilast 30 mg orally BID from Week 16 up to Week 52 in Period B. For those taking apremilast in Period B, non-responders at Week 28 and Week 40 will be offered to receive risankizumab as rescue medication.

Drug: Risankizumab; Drug: Apremilast

Interventions

Risankizumab DRUG

Subcutaneous injection

Also known as: ABBV-066, Skyrizi

Apremilast; Risankizumab

Apremilast DRUG

Oral Tablets

Also known as: Otezla

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Candidates for systemic therapy with moderate chronic plaque 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 \<= 15%; and
• Psoriasis Area and Severity Index (PASI) \>= 12; and
• Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).

You may not qualify if:

• Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
• History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
• 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).
• Prior exposure to risankizumab or apremilast.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (54)

Total Skin and Beauty Dermatology Center /ID# 233793

Birmingham, Alabama, 35205, United States

Location

Advanced Research Associates - Glendale /ID# 229266

Glendale, Arizona, 85308, United States

Location

Alliance Dermatology and MOHs Center, PC /ID# 229224

Phoenix, Arizona, 85032, United States

Location

UC Davis Health /ID# 229133

Sacramento, California, 95816-3300, United States

Location

Florida Academic Centers Research and Education /ID# 229235

Coral Gables, Florida, 33134, United States

Location

Olympian Clinical Research - Largo /ID# 233792

Largo, Florida, 33770, United States

Location

Renstar Medical Research /ID# 228946

Ocala, Florida, 34470, United States

Location

ForCare Clinical Research /ID# 229135

Tampa, Florida, 33613-1244, United States

Location

Arlington Dermatology /ID# 228945

Rolling Meadows, Illinois, 60008, United States

Location

Dawes Fretzin, LLC /ID# 229010

Indianapolis, Indiana, 46256, United States

Location

Epiphany Dermatology of Kansas LLC /ID# 229221

Overland Park, Kansas, 66210, United States

Location

DermAssociates, LLC /ID# 229016

Rockville, Maryland, 20850, United States

Location

Michigan Center for Research Company /ID# 229136

Clarkston, Michigan, 48346, United States

Location

Henry Ford Medical Center /ID# 229215

Detroit, Michigan, 48202-3046, United States

Location

MediSearch Clinical Trials /ID# 229269

Saint Joseph, Missouri, 64506, United States

Location

Physician Research Collaboration, LLC /ID# 229225

Lincoln, Nebraska, 68516, United States

Location

Advanced Dermatology of the Midlands /ID# 229009

Omaha, Nebraska, 68144-1105, United States

Location

Psoriasis Treatment Center of Central New Jersey /ID# 228943

East Windsor, New Jersey, 08520, United States

Location

University Hospitals Case Medical Center /ID# 229240

Cleveland, Ohio, 44106, United States

Location

Wright State Physicians - Fairborn /ID# 230051

Fairborn, Ohio, 45324-2640, United States

Location

Oregon Dermatology and Research Center /ID# 233462

Portland, Oregon, 97210, United States

Location

Arlington Research Center, Inc /ID# 229264

Arlington, Texas, 76011, United States

Location

Bellaire Dermatology Associates /ID# 230118

Bellaire, Texas, 77401, United States

Location

Center for Clinical Studies - Houston (Binz) /ID# 229263

Houston, Texas, 77004-8097, United States

Location

Center for Clinical Studies - Houston (Binz) /ID# 229272

Houston, Texas, 77004-8097, United States

Location

Premier Clinical Research /ID# 229220

Spokane, Washington, 99202, United States

Location

Beacon Dermatology Inc /ID# 230121

Calgary, Alberta, T3E 0B2, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 230337

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research /ID# 230480

Surrey, British Columbia, V3V 0C6, Canada

Location

Karma Clinical Trials /ID# 230339

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Dermatrials Research /ID# 230119

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416

Newmarket, Ontario, L3Y 5G8, Canada

Location

K. Papp Clinical Research /ID# 230336

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research Inc. /ID# 230334

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478

Québec, Quebec, G1V 4X7, Canada

Location

Universitaetsklinikum Erlangen /ID# 229433

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Frankfurt /ID# 229431

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Muenster /ID# 229432

Munster, Lower Saxony, 48149, Germany

Location

DermaKiel Allergie und Haut Centrum /ID# 229630

Kiel, Schleswig-Holstein, 24148, Germany

Location

Fachklinik Bad Bentheim /ID# 231504

Bad Bentheim, 48455, Germany

Location

Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245

Bochum, 44793, Germany

Location

SRH Wald-Klinikum Gera /ID# 229445

Gera, 07548, Germany

Location

MENSINGDERMA research GmbH /ID# 229435

Hamburg, 22391, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434

Mahlow, 15831, Germany

Location

Rambam Health Care Campus /ID# 229620

Haifa, H_efa, 3109601, Israel

Location

Rabin Medical Center /ID# 229074

Haifa, H_efa, 4941492, Israel

Location

HaEmek Medical Center /ID# 231901

Afula, Southern District, 1834111, Israel

Location

The Chaim Sheba Medical Center /ID# 229075

Ramat Gan, Tel Aviv, 5265601, Israel

Location

High-Med Przychodnia Specjalistyczna /ID# 229023

Warsaw, Masovian Voivodeship, 01-817, Poland

Location

Royalderm Agnieszka Nawrocka /ID# 228973

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Dermed Centrum Medyczne Sp. z o.o /ID# 229051

Lodz, Łódź Voivodeship, 90-265, Poland

Location

Related Publications (1)

• Stein Gold LF, Bagel J, Tyring SK, Hong HC, Pavlovsky L, Vender R, Pinter A, Reich A, Drogaris L, Wu T, Patel M, Soliman AM, Photowala H, Stakias V, Richter S, Papp KA. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023 Oct 25;189(5):540-552. doi: 10.1093/bjd/ljad252.

  PMID: 37488811 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumab; apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 1, 2021
• Study Start: June 9, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CA (9); DE (9); PL (6); IL (4); US (26)