Clinical trial NCT04713592: 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
Official title: IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO)
Risankizumab
SKYRIZI
ABBV-066
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 16
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: 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:
measure: Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16
timeFrame: Baseline, Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 219197
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research /ID# 223349
state: Arkansas
city: Rogers
country: United States
facility: NW Arkansas Clinical Trials Center /ID# 231602
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 219195
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 219216
state: California
city: San Diego
country: United States
facility: Medderm Associates /ID# 219210
state: California
city: Centennial
country: United States
facility: Colorado Center for Dermatology, PLLC /ID# 219223
state: Colorado
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood /ID# 219184
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research, LLC /ID# 219175
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC /ID# 227754
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group /ID# 219202
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC /ID# 219224
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 219211
state: Illinois
city: Skokie
country: United States
facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 219219
state: Indiana
city: New Albany
country: United States
facility: The Dermatology Center PSC - New Albany /ID# 219183
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas LLC /ID# 219208
state: Kansas
city: Methuen
country: United States
facility: Allcutis Research LLC /ID# 222272
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC /ID# 219180
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center /ID# 219205
state: Michigan
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands /ID# 219207
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey /ID# 219201
state: New Jersey
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group /ID# 219200
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai /ID# 219206
state: New York
city: Columbus
country: United States
facility: ClinOhio Research Services /ID# 222298
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 219203
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence /ID# 223350
state: Rhode Island
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services /ID# 222275
state: South Carolina
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services /ID# 222299
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC /ID# 220930
state: Tennessee
city: Dallas
country: United States
facility: Menter Dermatology Res Inst /ID# 219161
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston (Binz) /ID# 219221
state: Texas
city: Salt Lake City
country: United States
facility: Advanced Clinical Research - Woseth Dermatology /ID# 224750
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc. /ID# 219181
state: Virginia
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 220940
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc. /ID# 220941
state: British Columbia
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc. /ID# 220938
state: New Brunswick
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc. /ID# 220934
state: Newfoundland and Labrador
city: Newmarket
country: Canada
facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto /ID# 220939
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc. /ID# 222126
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935
state: Quebec
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 218789
city: Carolina
country: Puerto Rico
facility: Alma M. Cruz Santana, MD-Private practice /ID# 218790
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 218788
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 218787
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC /ID# 218786
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto /ID# 220904
state: Vizcaya
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa /ID# 224911
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 220908
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga /ID# 220900
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 220907
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia /ID# 220898
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 220903
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 222492
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: