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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038694

Enrollment

646

Registered

2021-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M148- Arthropathies in other specified diseases classified elsewhere

Interventions

Intervention1: Secukinumab: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFS) for s.c. injection, once every 4 weeks for 2 years. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1.Signed informed consent must be obtained before any assessment is performed. 2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study. 3. Participant has completed the parent study until end of the follow-up period (unless otherwise specified in the parent protocol). 4. Participant is deriving benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement. 5. Participant is unable to obtain the marketed secukinumab formulation due to unavailable local registration or reimbursement.

Exclusion criteria

Exclusion criteria: 1. Participant has discontinued study treatment in the parent protocol for any reason. 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).

Design outcomes

Primary

Measure	Time frame
Long term safety as assessed by occurrence of AEs/SAEsTimepoint: Long term safety as assessed by occurrence of AEs/SAEs (Time frame- Up to 2 years)	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

Belgium, Brazil, Bulgaria, Colombia, Czech Republic, Egypt, France, Greece, Guatemala, India, Malaysia, Mexico, Norway, Poland, Republic of Korea, Russian Federation, South Africa, Spain, Sweden, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com912250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026