Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)

Study Purpose

This study is designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis will be assessed using the OMERACT enthesitis score.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient must be able to understand and communicate with the Investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed. 2. Male or female patients at least 18 years of age. 3. Diagnosis of PsA as per CASPAR with active PsA for at least 6 months and a TJC ≥ 3 of 78 and SJC ≥ 3 of 76 at Baseline. 4. Patients must have a total synovitis PDUS score ≥ 2 and inflammation related to PD signal ≥ 1 for at least 2 (affected joints as observed via PDUS) of 48 joints at the Screening visit and at the Baseline visit (before infusion). 5. At least 1 clinically-involved enthesitis site at Screening and at the Baseline visit (before infusion) defined by SPARCC index different from 0.

Exclusion Criteria:

1. 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. 2. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. 3. Any change in the dose of oral corticosteroids in the last 4 weeks prior to the Baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 4 weeks prior to the enrollment visit. 4. Patients who have previously been treated with TNFα inhibitors (investigational or approved). 5. History of hypersensitivity to the study drug or its excipients or to drugs of similar classes. 6. Previous treatment with any cell-depleting therapies including but not limited to anti CD20 investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti CD19). 7. Prohibited psoriasis treatments/medications with topical corticosteroids in the last 4 weeks prior to randomization. 8. Pregnant or nursing (lactating) women.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02662985
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis, Psoriatic

Additional Details

This is a 52-week, multicenter, international study consisting of a 2 to 4-week Screening period, a 12-week randomized, placebo-controlled double-blind treatment period (Period 1), a 12-week open-label treatment period (Period 2) and a 6-month open-label extension period (Period 3). Treatment Period 1 is a 12-week placebo-controlled, randomized period primarily designed to demonstrate the early and optimal efficacy of secukinumab vs.#46;placebo on joint synovitis using PDUS via the GLOESS and global entheseal score after 12 weeks of treatment. The main aim of Period 2 is to assess the maintenance or increased magnitude of treatment response on joint synovitis for patients from the original secukinumab groups and to assess the time course of response with secukinumab on joint synovitis in the original placebo group switched to secukinumab from Week 12. The main aim of Period 3 (extension period) is to allow patients who respond to secukinumab to extend study treatment up to Week 52 or until commercial drug becomes available, whichever occurs sooner.

Arms & Interventions

Arms

Active Comparator: Group 1

In Treatment Period-1: Patients in this group will be administered secukinumab with 12 weeks of treatment from baseline. In Treatment Period-2: Patients will continue to receive the same active dose of secukinumab every 4 weeks until Week 24 In Treatment Period 3 (extension period): the extension period is to allow responder patients the possibility to continue open-label secukinumab treatment up to Week 52

Placebo Comparator: Group 2

In Treatment Period-1: Patients will receive placebo at baseline and same time points as secukinumab until Week 8. In Treatment Period-2: Patients will commence open-label secukinumab every 4 weeks from Week 12, as follows, based on their clinical characteristics at Week 12 In Treatment Period-3: Open-label secukinumab will continue to be assigned to patients

Interventions

Drug: - AIN457 (secukinumab)

Is a recombinant monoclonal antibody which neutralizes the activity of IL-17A, and has been shown to be effective in treating patients with moderate-to-severe plaque psoriasis. Secukinumab 150 mg provided in 1 mL pre filled syringes (PFS) for s.c. injection. The 300 mg dose will be administered as 2 × PFS injections.

Drug: - Placebo

Secukinumab placebo provided in a 1 mL PFS for s.c. injection.

Contact a Trial Team

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Novartis Investigative Site, Beverly Hills, California

Status

Recruiting

Address

Novartis Investigative Site

Beverly Hills, California, 90211

Site Contact

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