Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

NCT02826603 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457A23262015-002898-37
• Study Type: interventional
• Target: 1,114
• Locations: 11 countries
• Sites: 154

Brief Summary

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

Conditions

Plaque Psoriasis

Keywords

Plaque psoriasis; secukinumab; ustekinumab; ain457; ain457a

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12

  Week 12

• Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4

  Week 4

• Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16

  Week 16

• Participants With IGA Mod 2011 0 or 1 at 16 Weeks

  Week 16

• Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12

  Week 12

Study Arms (2)

Secukinumab

EXPERIMENTAL

Secukinumab

Drug: Secukinumab

Ustekinumab

ACTIVE COMPARATOR

Ustekinumab

Drug: Ustekinumab

Interventions

Secukinumab DRUG

300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48

Secukinumab

Ustekinumab DRUG

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.

Ustekinumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (154)

Novartis Investigative Site

Anniston, Alabama, 36207, United States

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Novartis Investigative Site

Birmingham, Alabama, 35205, United States

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Novartis Investigative Site

Birmingham, Alabama, 35233, United States

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Novartis Investigative Site

Mobile, Alabama, 36608, United States

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Novartis Investigative Site

Glendale, Arizona, 85308, United States

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Novartis Investigative Site

Phoenix, Arizona, 85018, United States

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Novartis Investigative Site

Phoenix, Arizona, 85032, United States

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Novartis Investigative Site

Scottsdale, Arizona, 85259, United States

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Scottsdale, Arizona, 85260, United States

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Tucson, Arizona, 85724, United States

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Fort Smith, Arkansas, 72916, United States

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Hot Springs, Arkansas, 71913, United States

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Novartis Investigative Site

Rogers, Arkansas, 72758, United States

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Bakersfield, California, 93309, United States

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Beverly Hills, California, 90211, United States

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California City, California, 93405, United States

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Encinitas, California, 92024, United States

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Fresno, California, 93710, United States

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Fullerton, California, 92835, United States

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Irvine, California, 92697, United States

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Los Angeles, California, 90033, United States

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Oceanside, California, 92056, United States

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Sacramento, California, 95819, United States

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San Diego, California, 92103, United States

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San Diego, California, 92117, United States

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San Diego, California, 92123, United States

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Santa Monica, California, 90404, United States

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Santa Rosa, California, 95405, United States

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Denver, Colorado, 80220, United States

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Trumbull, Connecticut, 06611, United States

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Aventura, Florida, 33180, United States

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Boca Raton, Florida, 33486, United States

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Cape Coral, Florida, 33990, United States

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Coral Gables, Florida, 33134, United States

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Fort Myers, Florida, 33916, United States

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Jacksonville, Florida, 32216, United States

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Orange Park, Florida, 32073, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33624, United States

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West Palm Beach, Florida, 33409, United States

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Alpharetta, Georgia, 30022, United States

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Atlanta, Georgia, 30342, United States

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Macon, Georgia, 31217, United States

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Marietta, Georgia, 30060, United States

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Newnan, Georgia, 30263, United States

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Skokie, Illinois, 60077, United States

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Springfield, Illinois, 62703, United States

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Indianapolis, Indiana, 46256, United States

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New Albany, Indiana, 47150, United States

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Louisville, Kentucky, 40241, United States

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Owensboro, Kentucky, 42301, United States

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Owensboro, Kentucky, 42303, United States

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Baton Rouge, Louisiana, 70809, United States

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Lake Charles, Louisiana, 70601, United States

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Lake Charles, Louisiana, 70605, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70112, United States

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Rockville, Maryland, 20850, United States

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Rockville, Maryland, 20852, United States

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Beverly, Massachusetts, 01915, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Brighton, Massachusetts, 02135, United States

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Quincy, Massachusetts, 02169, United States

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Fridley, Minnesota, 55432, United States

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Jackson, Mississippi, 39216-4505, United States

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Saint Joseph, Missouri, 64506, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89128, United States

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East Windsor, New Jersey, 08520, United States

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Verona, New Jersey, 07044, United States

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Albuquerque, New Mexico, 87106, United States

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Forest Hills, New York, 11375, United States

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New York, New York, 10016, United States

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New York, New York, 10025 1737, United States

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New York, New York, 10075, United States

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Rochester, New York, 14623, United States

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Chapel Hill, North Carolina, 27516, United States

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27710, United States

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Greensboro, North Carolina, 27401, United States

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High Point, North Carolina, 27262, United States

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Rocky Mount, North Carolina, 27804, United States

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Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44106-5028, United States

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Columbus, Ohio, 43210, United States

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Dublin, Ohio, 43016, United States

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Fairborn, Ohio, 45324, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Oregon City, Oregon, 97045, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97223, United States

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Exton, Pennsylvania, 19341, United States

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Jenkintown, Pennsylvania, 19046, United States

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Pittsburgh, Pennsylvania, 15213-3403, United States

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Plymouth Meeting, Pennsylvania, 19462, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29407, United States

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Greer, South Carolina, 29651, United States

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Goodlettsville, Tennessee, 37072-2301, United States

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Knoxville, Tennessee, 37922, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Arlington, Texas, 76011, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77056, United States

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Pflugerville, Texas, 78660, United States

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San Antonio, Texas, 78229, United States

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Murray, Utah, 84107, United States

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Norfolk, Virginia, 23507, United States

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Everett, Washington, 98201, United States

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Seattle, Washington, 98101, United States

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Spokane, Washington, 99204, United States

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Walla Walla, Washington, 99362, United States

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Wenatchee, Washington, 98801, United States

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Madison, Wisconsin, 53717, United States

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St. John's, Newfoundland and Labrador, A1A 5E8, Canada

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Etobicoke, Ontario, M8X 1Y9, Canada

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Hamilton, Ontario, L8N 1V6, Canada

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Sainte-Hyacinthe, Quebec, J2S 66, Canada

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Hradec Králové, CZE, 500 05, Czechia

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Prague, 100 34, Czechia

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Guatemala City, 01010, Guatemala

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Guatemala City, 01015, Guatemala

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Debrecen, 4032, Hungary

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Pécs, 7632, Hungary

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Szeged, 6725, Hungary

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Kopavogur, 201, Iceland

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Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

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Johor Bahru, 80100, Malaysia

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Warsaw, Mazowian, 02 495, Poland

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Gdansk, 80-803, Poland

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Lodz, 90-265, Poland

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Lodz, 90-436, Poland

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Olsztyn, 10-045, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-507, Poland

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Košice, Slovak Republic, 040 15, Slovakia

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Bojnice, 972 01, Slovakia

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Bundang Gu, Gyeonggi-do, 13620, South Korea

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Seoul, Korea, 06351, South Korea

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Seoul, Seocho Gu, 06591, South Korea

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Gwangju, 61469, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Hanoi, 100000, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, 7000, Vietnam

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Related Publications (4)

• Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.

  PMID: 36334236 DERIVED

• Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.

  PMID: 34870789 DERIVED

• Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.

  PMID: 32365251 DERIVED

• Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.

  PMID: 30334147 DERIVED

MeSH Terms

Interventions

secukinumab; Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

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: November 30, 2015
• First Posted: July 11, 2016
• Study Start: June 22, 2016
• Primary Completion: July 9, 2018
• Study Completion: July 9, 2018
• Last Updated: July 9, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-06

Locations

HU (3); US (123); PL (7); GU (2); KR (6); VN (2); CZ (2); CA (4); IC (1); MY (2); SL (2)