Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis

NCT07039110 | Recruiting

• 1 other identifier: P25-187
• Study Type: observational
• Target: 700
• Locations: 8 countries
• Sites: 81

Brief Summary

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice. Risankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis; Moderate to Severe Plaque Psoriasis; Risankizumab

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1

  DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no at all) to 1 (a little).

  At 12 months

Study Arms (1)

Risankizumab

Participants will receive risankizumab as prescribed by their physician according to local label.

Eligibility Criteria

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

Study Population

Adult participants with moderate to severe plaque psoriasis who are prescribed risankizumab by their physician.

You may qualify if:

• Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.
• Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing/treatment guidelines.
• Decision to treat with risankizumab is made prior to and independently of study participation.

You may not qualify if:

• History of a sleep disorder diagnosis which the patient is currently being treated for.
• Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.
• Currently receiving other biologic treatments and/or small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (81)

Dermatology Research Institute - Blackfoot Trail /ID# 276722

Calgary, Alberta, T2J 7E1, Canada

RECRUITING

Rejuvenation Dermatology - Edmonton Downtown /ID# 276688

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

Winnipeg Clinic /ID# 276751

Winnipeg, Manitoba, R3C 1T6, Canada

RECRUITING

Wiseman Dermatology Research /ID# 276847

Winnipeg, Manitoba, R3M 3Z4, Canada

RECRUITING

Cca Medical Research /ID# 276944

Ajax, Ontario, L1S 7K8, Canada

RECRUITING

Quinte dermatology /ID# 277497

Belleville, Ontario, K8N 2S9, Canada

RECRUITING

Dermatrials Research /ID# 276714

Hamilton, Ontario, L8N 1Y2, Canada

COMPLETED

Lovegrove Dermatology /ID# 276797

London, Ontario, N6A 5R9, Canada

RECRUITING

Lynderm Research Inc /ID# 276755

Markham, Ontario, L3P 1X2, Canada

RECRUITING

Rejuvenation Dermatology Clinic Oakville /ID# 277492

Oakville, Ontario, L6H 6P8, Canada

RECRUITING

JRB Research inc. /ID# 277730

Ottawa, Ontario, K1K 4L2, Canada

RECRUITING

Factor Dermatology /ID# 278610

Ottawa, Ontario, K2A 2M3, Canada

RECRUITING

SKiN Centre for Dermatology /ID# 277594

Peterborough, Ontario, K9J 5K2, Canada

RECRUITING

Eternal Springtime Dermatology /ID# 278598

Thunder Bay, Ontario, P7C 4Y7, Canada

RECRUITING

North York Research /ID# 276835

Toronto, Ontario, M2N 3A6, Canada

RECRUITING

Toronto Dermatology Centre /ID# 276846

Toronto, Ontario, M3H 5Y8, Canada

RECRUITING

Centre for Medical and Surgical Dermatology /ID# 278775

Whitby, Ontario, L1N 8M7, Canada

RECRUITING

Dre Angelique Gagne-Henley M.D. inc. /ID# 276687

Saint-Jérôme, Quebec, J7Z 7E2, Canada

RECRUITING

Fakultní Nemocnice U Sv. Anny V Brně /ID# 275799

Brno, Brno-mesto, 656 91, Czechia

RECRUITING

Fakultni nemocnice Bulovka /ID# 275540

Prague, Central Bohemia, 180 81, Czechia

RECRUITING

Dermafit Centrum /ID# 275897

Pilsen, Plzeň Region, 323 00, Czechia

RECRUITING

Dermamedest /ID# 275898

Prague, Praha 2, 120 00, Czechia

RECRUITING

Nemocnice Ceske Budejovice /ID# 275541

České Budějovice, 370 01, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady /ID# 275800

Prague, 100 34, Czechia

RECRUITING

Chu de Dijon /ID# 279900

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

Centre Hospitalier de Niort Georges Renon /ID# 279604

Niort, Deux-Sevres, 79021, France

RECRUITING

Dr. Rima Mohty /ID# 279951

Beauvais, Oise, 60000, France

RECRUITING

Centre Hospitalier Du Mans /ID# 279899

Le Mans, Sarthe, 72037, France

RECRUITING

Hopital d'Instruction des Armees Sainte-Anne /ID# 278106

Toulon, Var, 83800, France

RECRUITING

Hôpitaux Drôme Nord - Romans /ID# 278109

Romans-sur-Isère, 26102, France

RECRUITING

Dr. med. Moritz Huber und Dr. med. Martin Heister /ID# 277627

Friedrichshafen, Baden-Wurttemberg, 88046, Germany

RECRUITING

Dermakulm /Id# 277864

Kulmbach, Bavaria, 95326, Germany

RECRUITING

Dermazent /Id# 280327

Munich, Bavaria, 80331, Germany

RECRUITING

Hautaerzte am Nauener Tor /ID# 284579

Potsdam, Brandenburg, 14469, Germany

RECRUITING

Universitaetsmedizin Mainz /ID# 278229

Mainz, Rhineland-Palatinate, 55131, Germany

NOT YET RECRUITING

Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 277628

Mölln, Schleswig-Holstein, 23879, Germany

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf /ID# 277164

Hamburg, 20246, Germany

RECRUITING

Cutaneum /ID# 277294

Hamburg, 20249, Germany

RECRUITING

Private Practice - Dr. Mario Pawlak /ID# 277465

Heilbad Heiligenstadt, 37308, Germany

RECRUITING

Hautarztpraxis Dr. Med. Ulrike Wiemers / Dr. Med. Franca Wiemers /ID# 277821

Leipzig, 04317, Germany

COMPLETED

Hautarztpraxis Schwelm /ID# 277464

Schwelm, 58332, Germany

RECRUITING

General Hospital Andreas Syggros /ID# 276826

Athens, Attica, 16121, Greece

RECRUITING

General Hospital Andreas Syggros /ID# 279246

Athens, Attica, 16121, Greece

RECRUITING

University General Hospital Attikon /ID# 278389

Chaïdári, Attica, 12462, Greece

RECRUITING

Tzaneio Prefecture General Hospital of Piraeus /ID# 276532

Piraeus, Attica, 18536, Greece

RECRUITING

Asklipieio General Hospital of Voula /ID# 278235

Voula, Attica, 16673, Greece

RECRUITING

The University Hospital of Larissa /ID# 276576

Larissa, Thessaly, 41110, Greece

RECRUITING

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 276488

Thessaloniki, 54643, Greece

RECRUITING

Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 276489

Thessaloniki, 54643, Greece

RECRUITING

Papageorgiou General Hospital /ID# 276487

Thessaloniki, 56429, Greece

RECRUITING

ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 277341

L’Aquila, L Aquila, 67100, Italy

RECRUITING

IRCCS Ospedale San Raffaele /ID# 277342

Milan, Milano, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 277713

Naples, Napoli, 80138, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 278080

Rome, Roma, 00168, Italy

RECRUITING

Ospedale San Martino /ID# 278984

Genova, 16132, Italy

RECRUITING

Gunma University Hospital /ID# 278497

Maebashi, Gunma, 371-8511, Japan

RECRUITING

Asahikawa Medical University Hospital /ID# 278981

Asahikawa-shi, Hokkaido, 078-8510, Japan

RECRUITING

Hokkaido University Hospital /ID# 278260

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Hosui General Medical Clinic /ID# 279520

Sapporo, Hokkaido, 0640807, Japan

RECRUITING

Kagoshima University Hospital /ID# 278514

Kagoshima, Kagoshima-ken, 890-8520, Japan

RECRUITING

Tokai University Hospital /ID# 278294

Isehara, Kanagawa, 259-1193, Japan

RECRUITING

Yokohama City University Hospital /ID# 278257

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine /ID# 278962

Kyoto, Kyoto, 602-8566, Japan

RECRUITING

Kawasaki Medical School Hospital /ID# 278259

Kurashiki, Okayama-ken, 701-0192, Japan

RECRUITING

University of the Ryukyus Hospital /ID# 278256

Ginowan-shi, Okinawa, 901-2725, Japan

RECRUITING

Kindai University Hospital /ID# 278258

Sakai-shi, Osaka, 590-0197, Japan

RECRUITING

The University of Osaka Hospital /ID# 278436

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Juntendo University Hospital /ID# 278495

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Seibo Hospital /ID# 279522

Shinjuku-ku, Tokyo, 161-8521, Japan

RECRUITING

Fukuoka University Hospital /ID# 278600

Fukuoka, 814-0180, Japan

RECRUITING

Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 278434

Osaka, 550-0006, Japan

RECRUITING

Tokyo Yamate Medical Center /ID# 278960

Tokyo, 169-0073, Japan

RECRUITING

Teikyo University Hospital /ID# 278228

Tokyo, 173-8605, Japan

RECRUITING

Nihon University Itabashi Hospital /ID# 279916

Tokyo, 173-8610, Japan

RECRUITING

Hospital Regional Universitario de Malaga /ID# 277220

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitario de León /ID# 277895

León, Leon, 24080, Spain

RECRUITING

Hospital General Universitario Santa María Del Rosell /ID# 277894

Cartagena, Murcia, 30203, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca /ID# 283338

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital General Universitario Morales Meseguer /ID# 283339

Murcia, 30008, Spain

RECRUITING

Complejo Hospitalario Universitario de Pontevedra /ID# 278085

Pontevedra, 36071, Spain

RECRUITING

Hospital Universitario De Toledo /ID# 277896

Toledo, 45007, Spain

RECRUITING

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Julieta Gonzalez Blanco

CONTACT

844-663-3742; julieta.gonzalezblanco@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

GR (9); DE (11); IT (5); JP (19); ES (7); CA (18); FR (6); CZ (6)