Safety and Efficacy of Secukinumab in Mild Psoriasis

NCT03131570 | Completed Phase 2 Results FDA Drug

• 1 other identifier: JKR-0937
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Chronic Plaque Psoriasis; Secukinumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Have 75% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI75)

  The percentage of subjects who have a reduction of 75% or more from baseline in the Psoriasis Area and Severity Index (PASI) at week 12 (PASI 75). Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)

  week 12

Secondary Outcomes (9)

• Percentage of Subjects Who Have 90% or More Reduction in [Psoriasis Area-and-severity Index Score (PASI)] (PASI90)

  week 12

• Percentage of Subjects Who Achieve a Physician Global Assessment (PGA) Score of 0 or 1 With at Least a 2-step Improvement From Baseline (PGA 0/1 Response Rate).

  week 12

• Percentage of Subjects Who Experience Psoriasis Relapse

  week 24 through week 72

• Percentage of Subjects Who Experience Severe Psoriasis Relapse

  Observation Period: week 24 through week 72.

• Percentage of Subjects Who Experience Psoriasis Relapse After Psoriasis is Cleared

  Observation Period: week 24 through week 72

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Drug: Secukinumab

Group 2

PLACEBO COMPARATOR

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.

Drug: Placebo followed by Secukinumab

Interventions

Secukinumab DRUG

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).

Also known as: COSENTYX

Group 1

Placebo followed by Secukinumab DRUG

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).

Also known as: Placebo followed by COSENTYX

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular)
• Has previously received Secukinumab or other biologics
• History of Inflammatory Bowel Disease (IBD)
• History of Rheumatoid Arthritis
• 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)
• Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
• Has recently received or is planning to receive a vaccination while on the study
• HIV positive
• Chronic untreated hepatitis C, positive hepatitis B surface antigen and acute hepatitis A infection
• 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.
• Any severe, progressive or uncontrolled medical condition at screening that in the judgment of the investigator prevents the subject from participating in the study.

Sponsors & Collaborators

• James G. Krueger, MD, PhD: lead
• Novartis: collaborator

Study Sites (1)

The Rockefeller Univesity

New York, New York, 10065, United States

Location

Related Publications (4)

• Kim J, Bissonnette R, Lee J, Correa da Rosa J, Suarez-Farinas M, Lowes MA, Krueger JG. The Spectrum of Mild to Severe Psoriasis Vulgaris Is Defined by a Common Activation of IL-17 Pathway Genes, but with Key Differences in Immune Regulatory Genes. J Invest Dermatol. 2016 Nov;136(11):2173-2182. doi: 10.1016/j.jid.2016.04.032. Epub 2016 May 13.

  PMID: 27185339 BACKGROUND

• Kim J, Oh CH, Jeon J, Baek Y, Ahn J, Kim DJ, Lee HS, Correa da Rosa J, Suarez-Farinas M, Lowes MA, Krueger JG. Molecular Phenotyping Small (Asian) versus Large (Western) Plaque Psoriasis Shows Common Activation of IL-17 Pathway Genes but Different Regulatory Gene Sets. J Invest Dermatol. 2016 Jan;136(1):161-172. doi: 10.1038/JID.2015.378.

  PMID: 26763436 BACKGROUND

• Kim J, Nadella P, Kim DJ, Brodmerkel C, Correa da Rosa J, Krueger JG, Suarez-Farinas M. Histological Stratification of Thick and Thin Plaque Psoriasis Explores Molecular Phenotypes with Clinical Implications. PLoS One. 2015 Jul 15;10(7):e0132454. doi: 10.1371/journal.pone.0132454. eCollection 2015.

  PMID: 26176783 BACKGROUND

• Kim J, Krueger JG. The immunopathogenesis of psoriasis. Dermatol Clin. 2015 Jan;33(1):13-23. doi: 10.1016/j.det.2014.09.002.

  PMID: 25412780 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. James G. Krueger
• Organization: ROCKEFELLER UNIVERSITY

KRUEGEJ@MAIL.ROCKEFELLER.EDU

2123277409

Study Officials

• James G Krueger, MD, PhD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Laboratory for Investigative Dermatology

Model Details: To compare the secukinumab-receiving mild psoriasis subjects (Group 1) and the placebo-receiving mild psoriasis subjects (Group 2).

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 27, 2017
• Study Start: May 23, 2017
• Primary Completion: January 8, 2020
• Study Completion: June 21, 2021
• Last Updated: October 21, 2022
• Results First Posted: November 1, 2021

Record last verified: 2022-09

Locations

US (1)