Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

— CLARITY  

Official title:

A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826603
• Other study ID #: CAIN457A2326
• Secondary ID: 2015-002898-37
• Status: Completed
• Phase: Phase 3
• Start date: June 22, 2016
• Est. completion date: July 9, 2018

Study information

• Verified date: June 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1114
• Est. completion date: July 9, 2018
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must give a written, signed and dated informed consent

• Chronic plaque-type psoriasis present for at least 6 months before randomization

• Moderate to severe plaque psoriasis as defined at randomization by:

• PASI score of =12 and

• Body Surface Area (BSA) affected by plaque-type psoriasis =10% and

• IGA mod 2011 =3 (based on a scale of 0-4)

• Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:

• Topical treatment (including topical corticosteroids) and/or

• Phototherapy and/or

• Previous systemic therapy

Exclusion Criteria:

• Forms of psoriasis other than plaque psoriasis

• Drug-induced psoriasis

• Ongoing use of prohibited treatments

• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23

• Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation

• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Secukinumab
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
• Ustekinumab
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Etobicoke	Ontario
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Sainte-Hyacinthe	Quebec
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Czechia	Novartis Investigative Site	Hradec Kralove	CZE
Czechia	Novartis Investigative Site	Praha 10
Guatemala	Novartis Investigative Site	Guatemala
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
Iceland	Novartis Investigative Site	Kopavogur
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Malaysia	Novartis Investigative Site	Johor Bahru
Malaysia	Novartis Investigative Site	Kuala Lumpur	Wilayah Persekutuan
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa	Mazowian
Slovakia	Novartis Investigative Site	Bojnice
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Alpharetta	Georgia
United States	Novartis Investigative Site	Anderson	South Carolina
United States	Novartis Investigative Site	Anniston	Alabama
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Aventura	Florida
United States	Novartis Investigative Site	Bakersfield	California
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Beverly	Massachusetts
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boca Raton	Florida
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Brighton	Massachusetts
United States	Novartis Investigative Site	California City	California
United States	Novartis Investigative Site	Cape Coral	Florida
United States	Novartis Investigative Site	Chapel Hill	North Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Coral Gables	Florida
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Dublin	Ohio
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	East Windsor	New Jersey
United States	Novartis Investigative Site	Encinitas	California
United States	Novartis Investigative Site	Everett	Washington
United States	Novartis Investigative Site	Exton	Pennsylvania
United States	Novartis Investigative Site	Fairborn	Ohio
United States	Novartis Investigative Site	Forest Hills	New York
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Fort Smith	Arkansas
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Fridley	Minnesota
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Glendale	Arizona
United States	Novartis Investigative Site	Goodlettsville	Tennessee
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greer	South Carolina
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Hot Springs	Arkansas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Irvine	California
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Jacksonville	Florida
United States	Novartis Investigative Site	Jenkintown	Pennsylvania
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lake Charles	Louisiana
United States	Novartis Investigative Site	Lake Charles	Louisiana
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Macon	Georgia
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Murfreesboro	Tennessee
United States	Novartis Investigative Site	Murray	Utah
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Albany	Indiana
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Newnan	Georgia
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Oceanside	California
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Orange Park	Florida
United States	Novartis Investigative Site	Oregon City	Oregon
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Pflugerville	Texas
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Plymouth Meeting	Pennsylvania
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Quincy	Massachusetts
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Rockville	Maryland
United States	Novartis Investigative Site	Rockville	Maryland
United States	Novartis Investigative Site	Rocky Mount	North Carolina
United States	Novartis Investigative Site	Rogers	Arkansas
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Saint Joseph	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Santa Monica	California
United States	Novartis Investigative Site	Santa Rosa	California
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Skokie	Illinois
United States	Novartis Investigative Site	South Miami	Florida
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Trumbull	Connecticut
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Verona	New Jersey
United States	Novartis Investigative Site	Walla Walla	Washington
United States	Novartis Investigative Site	Wenatchee	Washington
United States	Novartis Investigative Site	West Palm Beach	Florida
United States	Novartis Investigative Site	Winston-Salem	North Carolina
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Canada,  Czechia,  Guatemala,  Hungary,  Iceland,  Korea, Republic of,  Malaysia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12	Number of participants who achieved = 90% reduction in PASI compared to baseline.; Logistic regression analysis of PASI 90 response at Week 12; PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, upper limbs, trunk, lower limbs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4).	Week 12
Primary	Participants With IGA Mod 2011 0 or 1 at Week 12	Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)	Week 12
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12	Number of participants who achieved = 75% reduction in PASI at Week 12 compared to baseline.	Week 12
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4	Number of participants who achieved = 75% reduction in PASI at Week 4 compared to baseline.	Week 4
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16	Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.	Week 16
Secondary	Participants With IGA Mod 2011 0 or 1 at 16 Weeks	Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)	Week 16
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12	Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.	Week 12
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16	Number of participants who achieved = 75% reduction in PASI at Week 16 compared to baseline.	Week 16
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16	Number of participants who achieved = 90% reduction in PASI at Week 16 compared to baseline.	Week 16
Secondary	Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52	Number of participants who achieved = 90% reduction in PASI at Week 52 compared to baseline.	Week 52