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Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis (MATURE)

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ClinicalTrials.gov Identifier: NCT03589885
Recruitment Status : Not yet recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Placebo 2 mL auto-injector Drug: Placebo 1 mL prefilled syringe Drug: Secukinumab 2 mL auto-injector Drug: Secukinumab 1 mL prefilled syringe Phase 3

Detailed Description:
This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 19, 2018
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : May 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Placebo Comparator: Placebo 2 mL auto-injector
Placebo to secukinumab s.c., provided in 2 mL auto-injector form
Drug: Placebo 2 mL auto-injector

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 Name: Placebo

Placebo Comparator: Placebo 1 mL prefilled syringe
Placebo to secukinumab s.c., provided in 2 * 1 ml prefilled syringe form
Drug: Placebo 1 mL prefilled syringe

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 Name: Placebo

Experimental: Secukinumab 2 mL auto-injector
Secukinumab 300 mg provided in 2 mL auto-injector form
Drug: Secukinumab 2 mL auto-injector
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

Active Comparator: Secukinumab 1 mL prefilled syringe
Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL
Drug: Secukinumab 1 mL prefilled syringe
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




Primary Outcome Measures :
  1. PASI 75 response after 12 weeks of treatment [ Time Frame: 12 weeks ]

    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 intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4)


  2. IGA mod 2011 0 or 1 response after 12 weeks of treatment [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. PASI 90 response [ Time Frame: 12 weeks ]
    Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline

  2. PASI 50, 75, 90 and 100 and IGA mod 2011 0 or 1 response [ Time Frame: 52 weeks ]
    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

  3. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 52 weeks ]
    Clinical safety and tolerability will be assessed up to Week 52 by adverse events monitoring

  4. Successful self-injection [ Time Frame: From randomization until Week 28 ]
    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 SIAQ and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration.

  5. DLQI 0 or 1 score [ Time Frame: change from Baseline up to 52 weeks ]
    The impact of psoriasis on various aspects of subject's health-related quality of life assessed by the subject



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects eligible for inclusion in this study must fulfill all of the following criteria:

  1. 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 study consent according to local laws and regulations.
  2. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
  3. 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.
  4. 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:

  1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.
  2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have 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 will be considered not eligible for this study since UV light exposure is prohibited.

    Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.

  3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
  4. 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 has returned to baseline, whichever is longer; or longer if required by local regulations.
  5. 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.
  6. 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 is evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that have 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).
  7. History of hypersensitivity to any of study drug constituent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589885


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03589885     History of Changes
Other Study ID Numbers: CAIN457A2325
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Plaque psoriasis, auto-injector, 2 mL injection, secukinumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs