Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Psoriatic Arthritis

ClinicalTrials.gov Identifier: NCT04209205

Novartis Reference Number: CAIN457P12302

Last Update: Dec 03, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Condition 
Psoriatic Arthritis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jan 29, 2020
Completion date 
May 18, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Secukinumab
Subjects will receive secukinumab i.v. (6 mg/kg) at BSL, followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through week 52).
Drug
Placebo
Subjects will receive placebo i.v. at BSL, Week 4, 8 and 12 followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 16 through Week 48 (exposure through week 52).

Eligibility Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
Rheumatoid factor and anti-CCP antibodies negative at screening
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis
Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 16
Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash-out periods need to be observed:
Oral or topical retinoids- 4 weeks
Photochemotherapy (e.g. PUVA)- 4 weeks
Phototherapy (UVA or UVB)- 2 weeks
Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks
Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization.
Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization.
Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved).
Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα.
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Study Locations

Brazil
Novartis Investigative Site
Recruiting
Sao Jose do Rio Preto, 15090 000
-
Brazil

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]