4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

NCT01640951 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457A2304E12012-000985-39
• Study Type: interventional
• Target: 675
• Locations: 15 countries
• Sites: 111

Brief Summary

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

Conditions

Moderate to Severe Chronic Plaque-Type Psoriasis

Keywords

Psoriasis; Plaque; Inflammatory skin disease; Scaly patches; AIN457; Secukinumab; Moderate to Severe Plaque-type Psoriasis

Outcome Measures

Primary Outcomes (1)

• Long-term Safety and Tolerability of Secukinumab

  Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)

  Week 268

Secondary Outcomes (10)

• Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260

  Week 52, Week 104, Week 156, Week 208, Week 260

• Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260

  Week 52, Week 104, Week 156, Week 208, Week 260

• Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260

  Baseline, Week 52, Week 104, Week 156, Week 208, Week 260

• Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260

  Week 52, Week 104, Week 156, Week 208, Week 260

• Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260

  Baseline, Week 52, Week 104, Week 156, Week 208, Week 260

Study Arms (5)

AIN457 150 mg - Fixed Interval (FI)

EXPERIMENTAL

1 s.c. Secukinumab 150 mg Pre-filled seringue (PFS) injection + 1 s.c. Placebo (PBO) Secukinumab PFS injection every 4 weeks

Drug: AIN457 150 mg; Drug: Placebo

AIN457 150 mg - Start of relapse (SoR)

EXPERIMENTAL

Start of relapse: 1 s.c. Secukinumab 150 mg PFS injection + 1 s.c. PBO Secukinumab PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Drug: AIN457 150 mg; Drug: Placebo

AIN457 300 mg - Fixed Interval (FI)

EXPERIMENTAL

2 s.c. Secukinumab 150 mg PFS injections every 4 weeks

Drug: AIN457 300 mg

AIN457 300 mg - Start of Relapse (SoR)

EXPERIMENTAL

Start of relapse: 2 s.c. Secukinumab 150 mg PFS injection every 4 weeks Otherwise: 2 s.c. PBO Secukinumab PFS injections every 4 weeks

Drug: AIN457 300 mg; Drug: Placebo

AIN457 300 mg - Open Label (OL)

EXPERIMENTAL

Open Label - Secukinumab 300mg every 4 weeks

Drug: AIN457 300 mg

Interventions

AIN457 150 mg DRUG

(1 injection per dose) and placebo to Secukinumab 150 mg

Also known as: Secukinumab 150 mg

AIN457 150 mg - Fixed Interval (FI); AIN457 150 mg - Start of relapse (SoR)

AIN457 300 mg DRUG

Secukinumab 150 mg (2 injections per dose)

Also known as: Secukinumab 300 mg

AIN457 300 mg - Fixed Interval (FI); AIN457 300 mg - Open Label (OL); AIN457 300 mg - Start of Relapse (SoR)

Placebo DRUG

AIN457 150 mg - Fixed Interval (FI); AIN457 150 mg - Start of relapse (SoR); AIN457 300 mg - Start of Relapse (SoR)

Eligibility Criteria

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

You may qualify if:

• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations.
• Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307
• Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator

You may not qualify if:

• A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject
• Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study.
• Subjects expected to be exposed to an undue safety risk if participating in the trial
• Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial
• Plans for administration of live vaccines during the study period
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (111)

Novartis Investigative Site

Fresno, California, 93710, United States

Location

Novartis Investigative Site

Pasadena, California, 91105, United States

Location

Novartis Investigative Site

San Francisco, California, 94118, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32204, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32216, United States

Location

Novartis Investigative Site

Miami, Florida, 33136, United States

Location

Novartis Investigative Site

South Miami, Florida, 33143, United States

Location

Novartis Investigative Site

West Palm Beach, Florida, 33409, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30342, United States

Location

Novartis Investigative Site

Champaign, Illinois, 61820, United States

Location

Novartis Investigative Site

Skokie, Illinois, 60077, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46256, United States

Location

Novartis Investigative Site

Overland Park, Kansas, 66215, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02111, United States

Location

Novartis Investigative Site

Fridley, Minnesota, 55432, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63117, United States

Location

Novartis Investigative Site

Henderson, Nevada, 89052, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89119, United States

Location

Novartis Investigative Site

Verona, New Jersey, 07044, United States

Location

Novartis Investigative Site

Greensboro, North Carolina, 27401, United States

Location

Novartis Investigative Site

High Point, North Carolina, 27262, United States

Location

Novartis Investigative Site

Winston-Salem, North Carolina, 27103, United States

Location

Novartis Investigative Site

Anderson, South Carolina, 29621, United States

Location

Novartis Investigative Site

Greer, South Carolina, 29651, United States

Location

Novartis Investigative Site

Goodlettsville, Tennessee, 37072-2301, United States

Location

Novartis Investigative Site

Dallas, Texas, 75231, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84124, United States

Location

Novartis Investigative Site

Wels, 4600, Austria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Sofia, 1231, Bulgaria

Location

Novartis Investigative Site

Sofia, 1404, Bulgaria

Location

Novartis Investigative Site

Sofia, 1431, Bulgaria

Location

Novartis Investigative Site

Varna, 9010, Bulgaria

Location

Novartis Investigative Site

Barrie, Ontario, L4M 6L2, Canada

Location

Novartis Investigative Site

Oakville, Ontario, L6J 7W5, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Windsor, Ontario, N8W 1E6, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2K 4L5, Canada

Location

Novartis Investigative Site

Brno-Bohunice, Czech Republic, 625 00, Czechia

Location

Novartis Investigative Site

Hradec Králové, CZE, 500 05, Czechia

Location

Novartis Investigative Site

Prague, CZE, 180 81, Czechia

Location

Novartis Investigative Site

České Budějovice, 370 01, Czechia

Location

Novartis Investigative Site

Nový Jičín, 741 01, Czechia

Location

Novartis Investigative Site

Prague, 100 34, Czechia

Location

Novartis Investigative Site

Antony, 92160, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Pierre-Bénite, 69495, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Bad Wildbad, 75323, Germany

Location

Novartis Investigative Site

Bochum, 44793, Germany

Location

Novartis Investigative Site

Buchholz I. D. Nordheide, 21244, Germany

Location

Novartis Investigative Site

Dippoldiswalde-Schmiedeberg, 01744, Germany

Location

Novartis Investigative Site

Duisburg, 47166, Germany

Location

Novartis Investigative Site

Düsseldorf, D-40225, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79104, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hamburg, 22143, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Lübeck, 23538, Germany

Location

Novartis Investigative Site

Mahlow, 15831, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Wuppertal, 42103, Germany

Location

Novartis Investigative Site

Roma, RM, 00133, Italy

Location

Novartis Investigative Site

Roma, RM, 00144, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Verona, VR, 37126, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Kisarazu, Chiba, 292-8535, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 815-8588, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 800-0296, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 078-8510, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-0033, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 550-0012, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 193-0944, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Novartis Investigative Site

Lodz, 90-265, Poland

Location

Novartis Investigative Site

Poznan, 60 529, Poland

Location

Novartis Investigative Site

Wroclaw, 50-368, Poland

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 308205, Singapore

Location

Novartis Investigative Site

Košice, Slovak Republic, 040 15, Slovakia

Location

Novartis Investigative Site

Košice, 04011, Slovakia

Location

Novartis Investigative Site

Poprad, 05845, Slovakia

Location

Novartis Investigative Site

Svidník, 089 01, Slovakia

Location

Novartis Investigative Site

Žilina, 01207, Slovakia

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Leytonstone, London, E11 1NR, United Kingdom

Location

Novartis Investigative Site

Birmingham, B15 2WB, United Kingdom

Location

Novartis Investigative Site

Blackpool, FY3 7EN, United Kingdom

Location

Novartis Investigative Site

Leicester, LE7 5WW, United Kingdom

Location

Novartis Investigative Site

Poole, BH15 2JB, United Kingdom

Location

Novartis Investigative Site

Ho Chi Minh City, VNM, 700000, Vietnam

Location

Novartis Investigative Site

Hanoi, 100000, Vietnam

Location

Novartis Investigative Site

Hanoi, 1000, Vietnam

Location

Novartis Investigative Site

Ho Chi Minh City, 7000, Vietnam

Location

Related Publications (1)

• Bissonnette R, Luger T, Thaci D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

  PMID: 28580579 DERIVED

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid; Dermatitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: September 16, 2012
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: May 25, 2018
• Results First Posted: May 25, 2018

Record last verified: 2018-04

Locations

CZ (6); FR (5); BU (5); PL (3); DE (20); SG (2); IT (4); GB (5); CA (5); JP (15); VN (4); CH (3); AU (1); SL (5); US (28)