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Safety and Efficacy of Secukinumab in Mild Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131570
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
James G. Krueger, MD, PhD, Rockefeller University

Tracking Information
First Submitted Date  ICMJE March 10, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date August 31, 2020
Actual Study Start Date  ICMJE May 23, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Proportion of subjects who have 75% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI75) [ Time Frame: week 12 ]
The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) at week 12.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Proportion of subjects who have 90% or more reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90) [ Time Frame: week 12 ]
    The proportion of subjects who have a reduction of 90% or more from baseline in the psoriasis area-and severity index score (PASI 90) at week 12.
  • Proportion of subjects who achieve a score of 0 on a 5-point modified Investigator's Global Assessment (IGA0) [ Time Frame: week 12 ]
    The proportion of subjects who achieve a score of 0 (clear) on a 5-point modified investigator's global assessment (IGA) at week 12.
  • Proportion of subjects who experience psoriasis relapse [ Time Frame: week 24 through week 72 ]
    The proportion of subjects who experience a psoriasis relapse at any time between week 24 and week 72. Psoriasis relapse is defined as loss of > 50% of the initial PASI improvement measured at week 24.
  • Severity of relapses [ Time Frame: Observation Period: week 24 through week 72. ]
    Severity of the relapses over the observation period.
  • Extent of relapses measured by the proportion of relapse frequencies between subjects who achieve clearance of psoriasis and subjects who do not achieve clearance of psoriasis. [ Time Frame: Observation Period: week 24 through week 72 ]
    Extent of relapses measured by the proportion of relapse frequencies between subjects who achieve a score of 0 (clear) on IGA (Investigator's Global Assessment) and subjects who do not achieve a score of 0 (clear) on IGA over the observation period.
  • Elapsed time until relapse [ Time Frame: week 24 until week 72 ]
    Elapsed time from week 24 until relapse occurs before week 72, measured in weeks.
  • Proportion of subjects who have 90% or 100% reduction in [Psoriasis area-and-severity index score (PASI)] (PASI90 or PASI100) [ Time Frame: week 12 ]
    The proportion of subjects who have a reduction of 90% or 100% from baseline in the psoriasis area-and severity index score (PASI90 or PASI100) at week 12.
  • Frequency of Adverse Events and Serious Adverse Events [ Time Frame: week 0 through week 72 ]
    Frequency of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).
  • Severity of Adverse Events and Serious Adverse Events [ Time Frame: week 0 through week 72 ]
    Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur during the whole trial including the observational period (AEs and SAEs include but not limited to comorbidities, such as hypertension, diabetes, and cardiovascular diseases).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Secukinumab in Mild Psoriasis
Official Title  ICMJE Safety and Efficacy of Secukinumab in Adults With Chronic Plaque Type Psoriasis With a PASI Score of 6 to 12
Brief Summary Mild psoriasis not only progresses to moderate-to-severe psoriasis but also precedes systemic inflammation that leads to psoriatic arthritis and cardiovascular comorbidities. By curing mild psoriasis with a short-term anti- interleukin (IL)-17A treatment, investigators may reduce the costs of treating psoriasis and associated medical conditions, including psoriatic arthritis, cardiovascular disease, and diabetes.
Detailed Description Psoriasis is an immune-mediated disease of the skin that, even in mild disease, increases the risk of comorbidities such as cardiovascular disease and metabolic derangements. Mild psoriasis tends to be treated with topical drugs, while moderate-to-severe disease is optimally treated with systemic immune modulators. However, the treatment of "mild" psoriasis needs to be re-thought because recent studies have revealed that mild psoriasis is characterized by stronger expression of pathogenic molecules, such as interleukin (IL)-17A, and higher numbers of T cells in the skin, compared to severe psoriasis. A key distinction between mild and severe psoriasis is now discovered to be the higher expression of negative immune regulatory genes in mild lesions. Therefore, targeted immune therapy with anti-IL-17A, which is highly effective in severe psoriasis, might be equally (or even more) effective in mild disease. Also, restoration of immune tolerance might be more easily achieved in mild disease. Thus, short-term anti-IL-17A treatment of mild psoriasis might prevent the recurrence and eventually cure the disease. The aim of study is to test this hypothesis by exploring whether 3 months or 6 months of anti-IL17A treatment will prevent relapses after medication has been discontinued in mild psoriasis patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
To compare the secukinumab-receiving mild psoriasis subjects (Group 1) and the placebo-receiving mild psoriasis subjects (Group 2).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: Secukinumab
    Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
    Other Name: COSENTYX
  • Drug: Placebo followed by Secukinumab
    Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
    Other Name: Placebo followed by COSENTYX
Study Arms  ICMJE
  • Experimental: Group 1
    6 months of Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period.
    Intervention: Drug: Secukinumab
  • Placebo Comparator: Group 2
    Placebo followed by Secukinumab. 3 months of placebo followed by 3 months of Secukinumab at a dose of 300 mg with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period.
    Intervention: Drug: Placebo followed by Secukinumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 3, 2020)
24
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
40
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed
  2. 18 years of age or older
  3. Chronic plaque-type psoriasis for at least 6 months
  4. Negative PPD (negative chest w-ray if positive) or negative QuantiFERON-TB Gold
  5. Have a PASI between 6 and 12 and Body Surface Area (BSA) affected by plaque-type psoriasis less than 10% at screening and baseline
  6. Willing to wash off steroid creams and ultraviolet B light (UVB) therapy for 2 weeks prior to the baseline visit

Exclusion Criteria:

  1. Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular)
  2. Has previously received Secukinumab or other biologics
  3. History of Inflammatory Bowel Disease (IBD)
  4. History of Rheumatoid Arthritis
  5. Use of topical treatments for psoriasis, including steroids, vitamin D derivatives, vitamin A derivatives, salicylic acid, tar (except moisturizers) and/or ultraviolet A light (UVA)/UVB phototherapy within the last 2 weeks (if these have used them, the participant needs to wash off of them for at least 2 weeks after signing consent prior to baseline)
  6. Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
  7. Has recently received or is planning to receive a vaccination while on the study
  8. HIV positive
  9. Chronic untreated hepatitis C, positive hepatitis B surface antigen and acute hepatitis A infection
  10. Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive QuantiFERON; TB test or a positive purified protein derivate (PPD) skin test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active TB.
  11. Any severe, progressive or uncontrolled medical condition at screening that in the judgment of the investigator prevents the subject from participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03131570
Other Study ID Numbers  ICMJE JKR-0937
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party James G. Krueger, MD, PhD, Rockefeller University
Study Sponsor  ICMJE James G. Krueger, MD, PhD
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: James G Krueger, MD, PhD Rockefeller University
PRS Account Rockefeller University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP