- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03589885
Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis (MATURE)
Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T5K 1X3
- Novartis Investigative Site
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Novartis Investigative Site
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Bielefeld, Germany, 33647
- Novartis Investigative Site
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Essen, Germany, 45147
- Novartis Investigative Site
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Vechta, Germany, 49377
- Novartis Investigative Site
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Witten, Germany, 58453
- Novartis Investigative Site
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Kopavogur, Iceland, 201
- Novartis Investigative Site
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Wroclaw, Poland, 50-566
- Novartis Investigative Site
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Mazowian
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Warszawa, Mazowian, Poland, 02 495
- Novartis Investigative Site
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Barcelona, Spain, 08003
- Novartis Investigative Site
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Madrid, Spain, 28041
- Novartis Investigative Site
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Madrid, Spain, 28031
- Novartis Investigative Site
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Comunidad Valenciana
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Alicante, Comunidad Valenciana, Spain, 03010
- Novartis Investigative Site
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Valencia, Comunidad Valenciana, Spain, 46014
- Novartis Investigative Site
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Florida
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Miami, Florida, United States, 33155
- Novartis Investigative Site
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Georgia
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Marietta, Georgia, United States, 30060
- Novartis Investigative Site
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Missouri
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Saint Joseph, Missouri, United States, 64506
- Novartis Investigative Site
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New Jersey
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Verona, New Jersey, United States, 07044
- Novartis Investigative Site
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Oregon
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Portland, Oregon, United States, 97210
- Novartis Investigative Site
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Texas
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Houston, Texas, United States, 77030
- Novartis Investigative Site
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San Antonio, Texas, United States, 78218
- Novartis Investigative Site
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Sugar Land, Texas, United States, 77479
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects eligible for inclusion in this study must have fulfilled all of the following criteria:
- Men or Women of at least 18 years of age at time of Screening
- Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
Moderate to severe psoriasis as defined at Randomization by:
- PASI score of 12 or greater, and
- IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
- Topical treatment and/or
- Phototherapy and/or
- Previous systemic therapy
Exclusion Criteria:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
Ongoing use of prohibited treatments. Washout periods detailed in the protocol had to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study were considered not eligible for this study since UV light exposure was prohibited.
Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was also prohibited.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect had returned to baseline, whichever is longer; or longer if required by local regulations.
- Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- History of hypersensitivity to any of study drug constituent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo 2 mL auto-injector
Placebo to secukinumab s.c., provided in 2 mL auto-injector form
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All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
Other Names:
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PLACEBO_COMPARATOR: Placebo 1 mL prefilled syringe
Placebo to secukinumab s.c., provided in 2 * 1 ml prefilled syringe form
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All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
Other Names:
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EXPERIMENTAL: Secukinumab 2 mL auto-injector
Secukinumab 300 mg provided in 2 mL auto-injector form
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2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48
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ACTIVE_COMPARATOR: Secukinumab 1 mL prefilled syringe
Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
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2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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PASI 75 Response After 12 Weeks of Treatment
Time Frame: 12 weeks
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Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline.
A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis.
The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72.
The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
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12 weeks
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IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment
Time Frame: 12 weeks
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Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline.
This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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PASI 90 Response
Time Frame: 12 weeks
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Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline
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12 weeks
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PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response
Time Frame: 52 weeks
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Percentage of participants who achieve ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline at each visit up to 52 weeks
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52 weeks
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Successful Self-injection
Time Frame: From randomization until Week 28
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Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration.
The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience).
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From randomization until Week 28
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Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)
Time Frame: Change from Baseline up to 52 weeks
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DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease.
The instrument contains ten items dealing with the participant's skin.
With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0).
Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively).
The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
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Change from Baseline up to 52 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAIN457A2325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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