Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

174

Study ID:

NCT04713592

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 53 Locations for this study

See Locations Near You

Advanced Research Associates - Glendale /ID# 219197
Glendale Arizona, 85308, United States
Burke Pharmaceutical Research /ID# 223349
Hot Springs Arkansas, 71913, United States
NW Arkansas Clinical Trials Center /ID# 231602
Rogers Arkansas, 72758, United States
Dermatology Research Associates /ID# 219195
Los Angeles California, 90045, United States
Integrative Skin Science and Research /ID# 219216
Sacramento California, 95815, United States
Medderm Associates /ID# 219210
San Diego California, 92103, United States
Colorado Center for Dermatology, PLLC /ID# 219223
Centennial Colorado, 80111, United States
Skin Care Research - Hollywood /ID# 219184
Hollywood Florida, 33021, United States
GSI Clinical Research, LLC /ID# 219175
Margate Florida, 33063, United States
Savin Medical Group, LLC /ID# 227754
Miami Lakes Florida, 33014, United States
Lenus Research & Medical Group /ID# 219202
Sweetwater Florida, 33172, United States
Hamilton Research, LLC /ID# 219224
Alpharetta Georgia, 30022, United States
Arlington Dermatology /ID# 219211
Rolling Meadows Illinois, 60008, United States
Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220
Skokie Illinois, 60077, United States
Dawes Fretzin, LLC /ID# 219219
Indianapolis Indiana, 46256, United States
The Dermatology Center PSC - New Albany /ID# 219183
New Albany Indiana, 47150, United States
Epiphany Dermatology of Kansas LLC /ID# 219208
Overland Park Kansas, 66210, United States
Allcutis Research LLC /ID# 222272
Methuen Massachusetts, 01844, United States
David Fivenson, MD, PLC /ID# 219180
Ann Arbor Michigan, 48103, United States
Henry Ford Medical Center /ID# 219205
Detroit Michigan, 48202, United States
Advanced Dermatology of the Midlands /ID# 219207
Omaha Nebraska, 68144, United States
Psoriasis Treatment Center of Central New Jersey /ID# 219201
East Windsor New Jersey, 08520, United States
Forest Hills Dermatology Group /ID# 219200
Kew Gardens New York, 11415, United States
Icahn School of Medicine at Mount Sinai /ID# 219206
New York New York, 10029, United States
ClinOhio Research Services /ID# 222298
Columbus Ohio, 43213, United States
University of Pittsburgh MC /ID# 219203
Pittsburgh Pennsylvania, 15260, United States
Velocity Clinical Research-Providence /ID# 223350
Warwick Rhode Island, 02886, United States
Palmetto Clinical Trial Services /ID# 222275
Fountain Inn South Carolina, 29644, United States
Palmetto Clinical Trial Services /ID# 222299
Fountain Inn South Carolina, 29644, United States
International Clinical Research - Tennessee LLC /ID# 220930
Murfreesboro Tennessee, 37130, United States
Menter Dermatology Res Inst /ID# 219161
Dallas Texas, 75246, United States
Center for Clinical Studies - Houston (Binz) /ID# 219221
Houston Texas, 77004, United States
Advanced Clinical Research - Woseth Dermatology /ID# 224750
Salt Lake City Utah, 84117, United States
Virginia Clinical Research, Inc. /ID# 219181
Norfolk Virginia, 23507, United States
Beacon Dermatology Inc /ID# 220940
Calgary Alberta, T3E 0, Canada
Dr. Chih-ho Hong Medical Inc. /ID# 220941
Surrey British Columbia, V3R 6, Canada
Dr. Irina Turchin PC Inc. /ID# 220938
Fredericton New Brunswick, E3B 1, Canada
NewLab Clinical Research Inc. /ID# 220934
St. John's Newfoundland and Labrador, A1C 2, Canada
Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936
Newmarket Ontario, L3Y 5, Canada
Research Toronto /ID# 220939
Toronto Ontario, M4W 2, Canada
Innovaderm Research Inc. /ID# 222126
Montréal Quebec, H2X 2, Canada
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935
Québec Quebec, G1V 4, Canada
Dr. Samuel Sanchez PSC /ID# 218789
Caguas , 00727, Puerto Rico
Cruz-Santana, Carolina, PR /ID# 218790
Carolina , 00985, Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 218788
Rio Piedras , 00935, Puerto Rico
Clinical Research Puerto Rico /ID# 218787
San Juan , 00909, Puerto Rico
GCM Medical Group, PSC /ID# 218786
San Juan , 00909, Puerto Rico
Hospital Regional de Malaga /ID# 220900
Málaga Malaga, 29010, Spain
Hospital Universitario Basurto /ID# 220904
Bilbao Vizcaya, 48013, Spain
Hospital Universitario de la Princesa /ID# 224911
Madrid , 28006, Spain
Hospital Universitario Ramon y Cajal /ID# 220908
Madrid , 28034, Spain
Hospital Universitario Virgen del Rocio /ID# 220907
Sevilla , 41013, Spain
Hospital General Universitario de Valencia /ID# 220898
Valencia , 46014, Spain
Hospital Universitario y Politecnico La Fe /ID# 220903
Valencia , 46026, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 222492
Zaragoza , 50009, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

174

Study ID:

NCT04713592

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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