Secukinumab Open Label Roll-over Extension Protocol

Conditions

• Autoimmunity, Inflammation

Eligibility Criteria

Sex

ALL

Age

6 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Secukinumab s.c. injection — BIOLOGICAL
  Secukinumab pre-filled syringes (PFS) for s.c. injection

Study Details

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.

Key Dates

Start date

Dec 22, 2020

Status verified

Jun 2026

Primary completion

Jan 29, 2030

Completion

Apr 4, 2030

Study Design

Enrollment

1,000 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab s.c.
  Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.

Primary Outcome Measure

To evaluate long term safety as assessed by occurrence of AEs/SAEs [ Time Frame: up to 2 years ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (28)

Find similar trials in Fullerton, CA