An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound (INTERCEPT)

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Psoriasis

Treatments: Other: Placebo; Biological: Secukinumab 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04488185

CAIN457AUS26

Details and patient eligibility

About

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of subclinical enthesitis in psoriasis patients. This study will be the first randomized trial of a biologic therapy versus placebo in participants with plaque psoriasis and subclinical psoriatic arthritis, using musculoskeletal ultrasound.

Full description

The primary objective of this study is to estimate the difference in effect between secukinumab 300 mg s.c. and placebo, based on change from baseline to Week 16 in the OMERACT ultrasound enthesitis score.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of chronic plaque-type psoriasis confirmed through physical examination by a dermatologist, with at least six months of clinical history prior to the baseline visit
• Moderate to severe plaque psoriasis at baseline as defined as:
• ≥ 10 % Body Surface Area (BSA) involvement, or
• ≥ 3% to <10% Body Surface Area with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent

Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies

Presence of sonographic enthesitis at screening, in at least one enthesis, defined by the presence of at least abnormal thickening and hypoechogenicity of the tendon insertion, with or without presence of Doppler signal (Grade 0-3), or by the presence of grade ≥ 2 Doppler signal, independent of gray scale abnormalities

Exclusion criteria

• Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints
• Exposure to any IL-17 or IL-23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within twelve months prior to screening, or exposure to any inhibitors of TNF-ɑ and IL12/23 within six months prior to screening
• Previous exposure to non-biologic systemic therapy for psoriasis, including methotrexate, PDE-4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half-lives (whichever is longer) prior to screening
• A degree of obesity that impedes proper ultrasound examination of entheses and joints
• Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g., erythrodermic, generalized or localized pustular psoriasis, or new onset guttate psoriasis)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Secukinumab 300mg

Experimental group

Description:

Randomized in a 2:1 ratio to secukinumab or placebo

Treatment:

Biological: Secukinumab 300 mg

Placebo

Placebo Comparator group

Description:

Randomized in a 2:1 ratio to secukinumab or placebo

Treatment:

Other: Placebo