Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
(ASLeap Trial)

Recruiting in Palo Alto (17 mi)

+60 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

Research Team

Eligibility Criteria

Inclusion Criteria

Key

Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent

Male or non-pregnant, non-lactating female patients at least 18 years of age

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Treatment Details

Interventions

Secukinumab (Monoclonal Antibodies)

Participant Groups

3Treatment groups

Active Control

Group I: Non-respondersActive Control1 Intervention

Patients who exhibit no change or an increase (worsening) from baseline in total Ankylosing Spondylitis Disease Activity Score (ASDAS) score at either Week 12 or Week 16. Non-responders were not entered Treatment Period 2. Non-responders were discontinued from the study at Week 16.

Group II: RespondersActive Control2 Interventions

Patients who achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (total score \<1.3) at both Week 12 and Week 16.

Group III: Inadequate respondersActive Control3 Interventions

Patients who have active disease, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) total score of \>1.3 at both Week 12 and Week 16, and who achieved a decrease (improvement) from baseline in total ASDAS score at both Week 12 and Week 16.