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Efficacy and Safety of 2 Secukinumab Regimens in 90 kg or Higher Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT03504852
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Demonstrate superiority of secukinumab high dose over standard dose in heavy body weight subjects with moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Plaque-type Psoriasis Drug: secukinumab 150 mg Phase 3

Detailed Description:

A 52-week multicenter, randomized, double-blind, parallel-group trial in approximately 330 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.

The study consists of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).

Subjects will be randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.

In addition, subjects from the 300 mg every 4 weeks group who do not achieve PASI 90 response at Week 16 will be randomized using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : March 25, 2021
Estimated Study Completion Date : March 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab 300 mg every 2 weeks
2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects will remain on secukinumab 300 mg every 2 weeks until the end of treatment
Drug: secukinumab 150 mg
sub-cutaneous secukinumab prefilled syringe 150 mg

Active Comparator: Secukinumab 300 mg every 4 weeks
2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 4 weeks. Starting at Week 6, 2 secukinumab placebo (dummy drug) injections will be alternated every 4 weeks to maintain the blind. Subjects in this arm who do not achieve PASI 90 response at Week 16 will be randomized at Baseline to either remain on secukinumab 300 mg every 4 weeks or to receive secukinumab 300 mg every 2 weeks starting at Week 16 until the end of the treatment period
Drug: secukinumab 150 mg
sub-cutaneous secukinumab prefilled syringe 150 mg




Primary Outcome Measures :
  1. PASI 90 Response [ Time Frame: 16 weeks ]
    Percentage of subjects who achieve 90% or greater reduction in PASI score compared to baseline


Secondary Outcome Measures :
  1. IGA mod 2011 0 or 1 response [ Time Frame: 16 weeks ]
    Percentage of subjects who achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline



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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

Key Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
  2. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study.
  3. Men or women at least 18 years of age at time of screening.
  4. Body weight of ≥ 90 kg at the time of randomization.
  5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
  6. Moderate to severe psoriasis as defined at randomization by:

    • Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
    • IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
    • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
  7. 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.

Key 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 Interleukin-17 (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 4 weeks 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
  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 skin 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 the study drug constituents.

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): NCT03504852


Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
United States, Maryland
Novartis Investigational Site Recruiting
Columbia, Maryland, United States, 21046
Contact: Study Lead         
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03504852     History of Changes
Other Study ID Numbers: CAIN457A2324
2015-004620-60 ( EudraCT Number )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 13, 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 ):
psoriasis
secukinumab
immune-mediated systemic disease
papules
plaques
itching

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