Clinical trial NCT01636687: Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentages of Subjects With Successful Self-administration of Study Drug at Week 1
timeFrame: Week 1
measure: Percentage of Subjects With Possible Use-related Hazards
timeFrame: Week 1
measure: Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
timeFrame: Week 12
measure: Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
timeFrame: Absolute change from baseline at week 48
measure: Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period
timeFrame: Week 12
measure: Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
timeFrame: Week 12 up to Week 52
measure: Absolute Change From Baseline for PASI Score - Induction Period
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)
timeFrame: Baseline, Week 52
measure: Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
timeFrame: Week 12
measure: Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
timeFrame: Week 52
measure: Change From Baseline in EQ-5D up to Week 12 - Induction Period
timeFrame: Week 12
measure: Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period
timeFrame: Week 52
measure: Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period
timeFrame: Baseline, up to Week 12
measure: Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period
timeFrame: Week 12
measure: Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)
timeFrame: Week 52
measure: Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
timeFrame: Week 160
measure: Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)
timeFrame: Week 160
measure: Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
timeFrame: Week 160
measure: Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies
timeFrame: Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Johnston
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississauga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Nice Cedex 3
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Osnabruck
country: Germany
facility: Novartis Investigative Site
city: Selters
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.