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

Plaque-type Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636687
• Other study ID #: CAIN457A2309
• Secondary ID: 2012-002609-22
• Status: Completed
• Phase: Phase 3
• Start date: October 17, 2012
• Est. completion date: October 27, 2016

Study information

• Verified date: September 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 27, 2016
• Est. primary completion date: October 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• Placebo
2 injections of placebo to secukinumab 150mg per dose
• Secukinumab 150mg
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 300mg
Secukinumab 300mg (2 injections of 150mg secukinumab per dose)

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Mississauga	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Sainte-Foy	Quebec
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
France	Novartis Investigative Site	Nice Cedex 3
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Toulouse Cedex
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Osnabruck
Germany	Novartis Investigative Site	Regensburg	Bavaria
Germany	Novartis Investigative Site	Selters
Germany	Novartis Investigative Site	Tuebingen
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Johnston	Rhode Island
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Oceanside	California
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Estonia,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentages of Subjects With Successful Self-administration of Study Drug at Week 1	To assess the subject's ability to follow instructions for use with the secukinumab autoinjector	Week 1
Secondary	Percentage of Subjects With Possible Use-related Hazards	To assess potential use-related hazards with the secukinumab autoinjector for the subject.	Week 1
Secondary	Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12	The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.	Week 12
Secondary	Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48	The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.	Absolute change from baseline at week 48
Secondary	Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period	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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving = 50%, 75%, 90% or 100% improvement from baseline.; The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 12
Secondary	Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)	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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving = 50%, 75%, 90% or 100% improvement from baseline.; The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 12 up to Week 52
Secondary	Absolute Change From Baseline for PASI Score - Induction Period	PASI: 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, arms, trunk, legs; 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 section(head:01, arms:0.2 body:0.3 legs:0.4)	Baseline, Week 12
Secondary	Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)	Psoriasis Area and Severity Index (PASI): 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, arms, trunk, legs; 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 section(head:01, arms:0.2 body:0.3 legs:0.4).	Baseline, Week 52
Secondary	Percentage of Participants in Each IGA Mod 2011 Category - Induction Period	The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe	Week 12
Secondary	Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)	The Investigators' Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 52
Secondary	Change From Baseline in EQ-5D up to Week 12 - Induction Period	ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).	Week 12
Secondary	Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period	ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).	Week 52
Secondary	Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.; A negative median percent change from baseline indicates improvement.	Baseline, up to Week 12
Secondary	Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.; A negative median percent change from baseline indicates improvement.	Baseline, Week 52
Secondary	Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.	Week 12
Secondary	Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)	The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.	Week 52
Secondary	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)	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, arms, trunk, legs; 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 section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving = 50%, 75%, 90% or 100% improvement from baseline.; The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 160
Secondary	Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)	PASI: 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, arms, trunk, legs; 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 section(head:01, arms:0.2 body:0.3 legs:0.4).	Week 160
Secondary	Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)	The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.	Week 160
Secondary	Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies	The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.	Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216