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

• Status: Recruiting
• Trial end date: 2022-05-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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)