Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

NCT04713592 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M15-9942020-000581-42
• Study Type: interventional
• Target: 174
• Locations: 4 countries
• Sites: 55

Brief Summary

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world. Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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.

Conditions

Psoriasis

Keywords

Psoriasis; Plaque Psoriasis; Moderate to Severe Plaque Psoriasis; Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO); Risankizumab; SKYRIZI; ABBV-066

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16

  The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

  Baseline, Week 16

• Number of Participants With Treatment-Emergent Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)

Secondary Outcomes (4)

• Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16

  Baseline, Week 16

• Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16

  Baseline, Week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.

Drug: Placebo for Risankizumab; Drug: Risankizumab

Risankizumab

EXPERIMENTAL

Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.

Drug: Risankizumab

Interventions

Placebo for Risankizumab DRUG

Subcutaneous (SC) Injection

Placebo

Risankizumab DRUG

Subcutaneous (SC) Injection

Also known as: ABBV-066, SKYRIZI

Placebo; Risankizumab

Eligibility Criteria

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

You may qualify if:

• Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.
• Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.
• Must be a candidate for systemic therapy as assessed by the investigator.
• Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.

You may not qualify if:

• History of PsO other than chronic plaque type PsO
• History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
• Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.
• Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.
• Prior exposure to risankizumab.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (55)

Advanced Research Associates - Glendale /ID# 219197

Glendale, Arizona, 85308, United States

Location

Burke Pharmaceutical Research /ID# 223349

Hot Springs, Arkansas, 71913-6404, United States

Location

NW Arkansas Clinical Trials Center /ID# 231602

Rogers, Arkansas, 72758, United States

Location

Dermatology Research Associates /ID# 219195

Los Angeles, California, 90045, United States

Location

Integrative Skin Science and Research /ID# 219216

Sacramento, California, 95815, United States

Location

Medderm Associates /ID# 219210

San Diego, California, 92103, United States

Location

Colorado Center for Dermatology, PLLC /ID# 219223

Centennial, Colorado, 80111-1724, United States

Location

Skin Care Research - Hollywood /ID# 219184

Hollywood, Florida, 33021-6748, United States

Location

GSI Clinical Research, LLC /ID# 219175

Margate, Florida, 33063, United States

Location

Savin Medical Group, LLC /ID# 227754

Miami Lakes, Florida, 33014-2490, United States

Location

Lenus Research & Medical Group /ID# 219202

Sweetwater, Florida, 33172, United States

Location

Hamilton Research, LLC /ID# 219224

Alpharetta, Georgia, 30022, United States

Location

Arlington Dermatology /ID# 219211

Rolling Meadows, Illinois, 60008, United States

Location

Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220

Skokie, Illinois, 60077, United States

Location

Dawes Fretzin, LLC /ID# 219219

Indianapolis, Indiana, 46256, United States

Location

The Dermatology Center PSC - New Albany /ID# 219183

New Albany, Indiana, 47150, United States

Location

Epiphany Dermatology of Kansas LLC /ID# 219208

Overland Park, Kansas, 66210, United States

Location

Allcutis Research LLC /ID# 222272

Methuen, Massachusetts, 01844-5864, United States

Location

David Fivenson, MD, PLC /ID# 219180

Ann Arbor, Michigan, 48103, United States

Location

Henry Ford Medical Center /ID# 219205

Detroit, Michigan, 48202-3046, United States

Location

Advanced Dermatology of the Midlands /ID# 219207

Omaha, Nebraska, 68144-1105, United States

Location

Psoriasis Treatment Center of Central New Jersey /ID# 219201

East Windsor, New Jersey, 08520, United States

Location

Forest Hills Dermatology Group /ID# 219200

Kew Gardens, New York, 11415, United States

Location

Icahn School of Medicine at Mount Sinai /ID# 219206

New York, New York, 10029-6504, United States

Location

ClinOhio Research Services /ID# 222298

Columbus, Ohio, 43213-4440, United States

Location

University of Pittsburgh MC /ID# 219203

Pittsburgh, Pennsylvania, 15260, United States

Location

Velocity Clinical Research-Providence /ID# 223350

East Greenwich, Rhode Island, 02818, United States

Location

Palmetto Clinical Trial Services /ID# 222275

Fountain Inn, South Carolina, 29644-1928, United States

Location

Palmetto Clinical Trial Services /ID# 222299

Fountain Inn, South Carolina, 29644-1928, United States

Location

International Clinical Research - Tennessee LLC /ID# 220930

Murfreesboro, Tennessee, 37130-2450, United States

Location

Menter Dermatology Res Inst /ID# 219161

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies - Houston (Binz) /ID# 219221

Houston, Texas, 77004-8097, United States

Location

Advanced Clinical Research - Woseth Dermatology /ID# 224750

Salt Lake City, Utah, 84117-4209, United States

Location

Virginia Clinical Research, Inc. /ID# 219181

Norfolk, Virginia, 23507, United States

Location

Beacon Dermatology Inc /ID# 220940

Calgary, Alberta, T3E 0B2, Canada

Location

Dr. Chih-ho Hong Medical Inc. /ID# 220941

Surrey, British Columbia, V3R 6A7, Canada

Location

Dr. Irina Turchin PC Inc. /ID# 220938

Fredericton, New Brunswick, E3B 1G9, Canada

Location

NewLab Clinical Research Inc. /ID# 220934

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936

Newmarket, Ontario, L3Y 5G8, Canada

Location

Research Toronto /ID# 220939

Toronto, Ontario, M4W 2N4, Canada

Location

Innovaderm Research Inc. /ID# 222126

Montreal, Quebec, H2X 2V1, Canada

Location

Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935

Québec, Quebec, G1V 4X7, Canada

Location

Dr. Samuel Sanchez PSC /ID# 218789

Caguas, 00727, Puerto Rico

Location

Alma M. Cruz Santana, MD-Private practice /ID# 218790

Carolina, 00985, Puerto Rico

Location

Pan American Center for Oncology Trials, LLC /ID# 218788

Rio Piedras, 00935, Puerto Rico

Location

Clinical Research Puerto Rico /ID# 218787

San Juan, 00909, Puerto Rico

Location

GCM Medical Group, PSC /ID# 218786

San Juan, 00917, Puerto Rico

Location

Hospital Universitario Basurto /ID# 220904

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitario de la Princesa /ID# 224911

Madrid, 28006, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 220908

Madrid, 28034, Spain

Location

Hospital Regional Universitario de Malaga /ID# 220900

Málaga, 29011, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 220907

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia /ID# 220898

Valencia, 46014, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 220903

Valencia, 46026, Spain

Location

Hospital Clinico Universitario Lozano Blesa /ID# 222492

Zaragoza, 50009, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis; Margins of Excision

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: February 26, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-06

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

ES (8); US (34); PR (5); CA (8)