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Secukinumab Open Label Roll-over Extension Protocol | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Secukinumab Open Label Roll-over Extension Protocol

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment

NCT04638647•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.

Eligibility

Age

6 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
•2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
•4. Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.
•5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

Exclusion Criteria

•1. Participant has prematurely discontinued study treatment in the parent protocol.
•2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).

Locations (167)

Providence Medical Foundation

Fullerton, California, United States

Purushotham Akther and Roshan Kotha MD Inc

La Mesa, California, United States

Precn Comprehensive Clnl Rsch Solns

San Leandro, California, United States

Orrin Troum MD and Medical Associates

Santa Monica, California, United States

Inland Rheumatology Clinical Trials INC

Upland, California, United States

Medvin Clinical Research

Van Nuys, California, United States

Center for Rheumatology Research

West Hills, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

Rheumatology Associates of South Florida

Boca Raton, Florida, United States

Homestead Assoc In Research Inc

Homestead, Florida, United States

Key Dates

Start Date

December 22, 2020

Primary Completion Date

January 29, 2030

Completion Date

April 4, 2030

Last Updated

March 11, 2026

Enrollment

1,000

ESTIMATED participants

Conditions

Autoimmunity, Inflammation

Interventions

Secukinumab s.c. injection

BIOLOGICAL

Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111