Study of efficacy and safety of secukinumab in Psoriatic Arthritis and axial Spondyloarthritis patients with active enthesitis including one Achilles tendon site (ACHILLES)

Phase 1

• Conditions: Psoriatic arthritis Axial spondyloarthritis; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000018188; MedDRA version: 20.0 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-000972-91-BG
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-07
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- Psoriatic arthritis patients must fulfill the following criteria:
Diagnosis of Psoriatic arthritis classified by Classification criteria for Psoriatic Arthritis (CASPAR criteria) with symptoms for at least 6 months and active Psoriatic arthritis as assessed by = 1 tender joints out of 78 and = 1 swollen joints out of 76 at Baseline (dactylitis of a digit counts as one joint each)
- Axial Spondyloarthritis patients must fulfill the following criteria:
Axial Spondyloarthritis as per the classification of the Assessment of Spondyloarthritis International Society axial Spondyloarthritis (ASAS) criteria with objective signs of inflammation at Screening (magnetic resonance imaging (MRI) with Sacroiliac joint inflammation or definite radiographic sacroilitis according to the modified New York (NY) criteria and/or abnormal high sensitivity C-Reactive Protein (hsCRP)) and active disease assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) = 4 (0–10) at Baseline
- Diagnosis of Achilles tendon enthesitis according to swelling and tenderness at the insertional site of the Achilles tendon into the calcaneus
- Onset of heel pain = 1 month up to 5 years at Baseline
- Heel enthesitis that is magnetic resonance imaging (MRI)-positive according to the investigator`s judgement
- Patients who haven been exposed to up to two TNFa inhibitors.

Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process
- Previous exposure to secukinumab or other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor
- Ongoing use of psoriasis treatments / medications (e.g. topical corticosteroids, ultraviolet (UV) therapy) at randomization
-Patients who have previously been exposed to more than two Tumor necrosis factor (TNF) inhibitors (investigational or approved).
- Patients who have ever received biologic immunomodulating agents (investigational or approved), except those targeting Tumor necrosis factor (TNF) inhibitors.
- Pregnant or nursing (lactating) women
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection

Other protocol defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified