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

Study Purpose

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.

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

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)

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.

NCT04209205
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.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Czechia, Malaysia, Russian Federation, Turkey, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Additional Details

This multicenter study uses a randomized, double-blind, placebo-controlled, parallel-group design. A screening (SCR) period running up to 10 weeks before randomization will be used to assess subject eligibility followed by a treatment period of 52 weeks. At baseline, approximately 380 patients with active psoriatic arthritis will be randomized to one of the two treatment groups in a 1:1 randomization: Group 1: Approximately 190 patients with active psoriatic arthritis; These patients will receive secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4. Group 2: Approximately 190 patients with active psoriatic arthritis; These patients will receive i.v. placebo at BSL and at Weeks 4, 8, and 12, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 16. Study will consist of 4 periods: a screening period (up to 10 weeks), treatment period 1 (total duration of 16 weeks) and treatment period 2 (total duration of 36 weeks) followed by a safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52). Primary endpoint analysis will be performed with Week 16 data (last patient completing Treatment period 1 (Week 16). Long-term efficacy and safety assessments will be performed up to Week 52.

Arms & Interventions

Arms

Experimental: Secukinumab

Secukinumab intravenous (i.v.) regimen

Placebo Comparator: Placebo

Placebo intravenous (i.v.) regimen

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Birmingham, Alabama

Status

Recruiting

Address

Novartis Investigative Site

Birmingham, Alabama, 35205

Novartis Investigative Site, La Mesa, California

Status

Recruiting

Address

Novartis Investigative Site

La Mesa, California, 91942

Novartis Investigative Site, Upland, California

Status

Recruiting

Address

Novartis Investigative Site

Upland, California, 91786

Novartis Investigative Site, West Hills, California

Status

Recruiting

Address

Novartis Investigative Site

West Hills, California, 91307

Novartis Investigative Site, Denver, Colorado

Status

Recruiting

Address

Novartis Investigative Site

Denver, Colorado, 80230

Novartis Investigative Site, Lewes, Delaware

Status

Recruiting

Address

Novartis Investigative Site

Lewes, Delaware, 19958

Novartis Investigative Site, Clearwater, Florida

Status

Recruiting

Address

Novartis Investigative Site

Clearwater, Florida, 33765

Novartis Investigative Site, Miami, Florida

Status

Recruiting

Address

Novartis Investigative Site

Miami, Florida, 33032

Novartis Investigative Site, Ocoee, Florida

Status

Recruiting

Address

Novartis Investigative Site

Ocoee, Florida, 34761

Novartis Investigative Site, Winter Park, Florida

Status

Recruiting

Address

Novartis Investigative Site

Winter Park, Florida, 32789

Novartis Investigative Site, Indianapolis, Indiana

Status

Recruiting

Address

Novartis Investigative Site

Indianapolis, Indiana, 46256

Novartis Investigative Site, Bowling Green, Kentucky

Status

Recruiting

Address

Novartis Investigative Site

Bowling Green, Kentucky, 42101

Novartis Investigative Site, Columbia, Maryland

Status

Recruiting

Address

Novartis Investigative Site

Columbia, Maryland, 21046

Novartis Investigative Site, Saint Louis, Missouri

Status

Recruiting

Address

Novartis Investigative Site

Saint Louis, Missouri, 63117

Novartis Investigative Site, Lincoln, Nebraska

Status

Recruiting

Address

Novartis Investigative Site

Lincoln, Nebraska, 68516

Novartis Investigative Site, Voorhees, New Jersey

Status

Recruiting

Address

Novartis Investigative Site

Voorhees, New Jersey, 08043

Novartis Investigative Site, Greensboro, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

Greensboro, North Carolina, 27408

Novartis Investigative Site, Oklahoma City, Oklahoma

Status

Recruiting

Address

Novartis Investigative Site

Oklahoma City, Oklahoma, 73103

Novartis Investigative Site, Duncansville, Pennsylvania

Status

Recruiting

Address

Novartis Investigative Site

Duncansville, Pennsylvania, 16635

Novartis Investigative Site, Mesquite, Texas

Status

Recruiting

Address

Novartis Investigative Site

Mesquite, Texas, 75150

Novartis Investigative Site, Newport News, Virginia

Status

Recruiting

Address

Novartis Investigative Site

Newport News, Virginia, 23608

Novartis Investigative Site, Charleston, West Virginia

Status

Recruiting

Address

Novartis Investigative Site

Charleston, West Virginia, 25304

International Sites

Novartis Investigative Site, Burgas, Bulgaria

Status

Recruiting

Address

Novartis Investigative Site

Burgas, , 8000

Novartis Investigative Site, Sofia, Bulgaria

Status

Recruiting

Address

Novartis Investigative Site

Sofia, , 1431

Novartis Investigative Site, Prague 2, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Prague 2, , 128 50

Novartis Investigative Site, Praha 4, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Praha 4, , 140 59

Novartis Investigative Site, Praha 5, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Praha 5, , 150 06

Novartis Investigative Site, Uherske Hradiste, Czechia

Status

Recruiting

Address

Novartis Investigative Site

Uherske Hradiste, , 686 01

Novartis Investigative Site, Seremban, Negeri Sembilan, Malaysia

Status

Recruiting

Address

Novartis Investigative Site

Seremban, Negeri Sembilan, 70300

Novartis Investigative Site, Selangor Darul Ehsan, Malaysia

Status

Recruiting

Address

Novartis Investigative Site

Selangor Darul Ehsan, , 68100

Novartis Investigative Site, Kemerovo, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Kemerovo, , 650029

Novartis Investigative Site, Nizhny Novgorod, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Nizhny Novgorod, , 603018

Novartis Investigative Site, Rostov on Don, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Rostov on Don, , 344022

Novartis Investigative Site, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Saint Petersburg, , 197022

Novartis Investigative Site, Yekaterinburg, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Yekaterinburg, , 620109

Novartis Investigative Site, Bursa, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Bursa, , 16059

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