Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)

NCT01636687 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CAIN457A23092012-002609-22
• Study Type: interventional
• Target: 182
• Locations: 5 countries
• Sites: 39

Brief Summary

The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Conditions

Plaque-type Psoriasis

Keywords

Psoriasis; Moderate to Severe Plaque-type Psoriasis; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response

  Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.

  12 weeks

Secondary Outcomes (20)

• Percentages of Subjects With Successful Self-administration of Study Drug at Week 1

  Week 1

• Percentage of Subjects With Possible Use-related Hazards

  Week 1

• Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12

  Week 12

• Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48

  Absolute change from baseline at week 48

• Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period

  Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects who were in placebo at Week 52 cannot continue in the extension treatment period

Drug: Placebo

Secukinumab 150 mg

EXPERIMENTAL

After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period.

Drug: Secukinumab 150mg

Secukinumab 300 mg

EXPERIMENTAL

After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.

Drug: Secukinumab 300mg

Interventions

Placebo DRUG

2 injections of placebo to secukinumab 150mg per dose

Placebo

Secukinumab 150mg DRUG

Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered

Secukinumab 150 mg

Secukinumab 300mg DRUG

Secukinumab 300mg (2 injections of 150mg secukinumab per dose)

Secukinumab 300 mg

Eligibility Criteria

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

You may qualify if:

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
• Severity of psoriasis disease meeting all of the following three criteria:
• Psoriasis Area and Severity Index (PASI) score of 12 or greater
• Investigator's Global Assessment (IGA) score of 3 or greater
• Total body surface area (BSA) affected of 10% or greater
• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

You may not qualify if:

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (39)

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

Location

Novartis Investigative Site

Los Angeles, California, 90045, United States

Location

Novartis Investigative Site

Oceanside, California, 92056, United States

Location

Novartis Investigative Site

Overland Park, Kansas, 66215, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40202, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40291, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68144, United States

Location

Novartis Investigative Site

Rochester, New York, 14623, United States

Location

Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Novartis Investigative Site

Johnston, Rhode Island, 02919, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Norfolk, Virginia, 23507, United States

Location

Novartis Investigative Site

Calgary, Alberta, T3A 2N1, Canada

Location

Novartis Investigative Site

Halifax, Nova Scotia, B3H 1Z2, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 1V6, Canada

Location

Novartis Investigative Site

Mississauga, Ontario, L5H 1G9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3H 1V4, Canada

Location

Novartis Investigative Site

Sainte-Foy, Quebec, G1V 4X7, Canada

Location

Novartis Investigative Site

Tallinn, 10134, Estonia

Location

Novartis Investigative Site

Tallinn, 13619, Estonia

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

Location

Novartis Investigative Site

Augsburg, 86163, Germany

Location

Novartis Investigative Site

Augsburg, 86179, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Gera, 07548, Germany

Location

Novartis Investigative Site

Hamburg, 22143, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Heidelberg, 69115, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Selters, 56242, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Related Publications (6)

• Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.

  PMID: 37341961 DERIVED

• Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

  PMID: 35305260 DERIVED

• Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

  PMID: 34110605 DERIVED

• Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.

  PMID: 27576559 DERIVED

• Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.

  PMID: 27573260 DERIVED

• Paul C, Lacour JP, Tedremets L, Kreutzer K, Jazayeri S, Adams S, Guindon C, You R, Papavassilis C; JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1082-90. doi: 10.1111/jdv.12751. Epub 2014 Sep 22.

  PMID: 25243910 DERIVED

MeSH Terms

Conditions

Psoriasis; Skin Diseases; Recurrence; Plaque, Amyloid; Pruritus

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Skin Manifestations; Signs and Symptoms

Limitations and Caveats

Efficacy results after Wk 160 can't be interpreted meaningfully due to low # of evaluable patients. As per protocol, availability of AIN457 in participating countries led to discontinuation of most patients before they reached the later visits.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

+1-862-778-8300

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: 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: July 6, 2012
• First Posted: July 10, 2012
• Study Start: October 17, 2012
• Primary Completion: October 27, 2016
• Study Completion: October 27, 2016
• Last Updated: September 27, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-09

Locations

FR (3); DE (16); CA (6); US (12); ES (2)