Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Secukinumab provided in pre-filled syringes · 1 trial · 1 indication
This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain
| Arm | Type | Description |
|---|---|---|
| secukinumab 150mg | EXPERIMENTAL | A screening (SCR) epoch running 4-10 weeks before baseline (BSL) was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consist of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 follows a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinue prematurely. |
| Name | Type | Description |
|---|---|---|
| Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. | DRUG | Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks. |
Inclusion Criteria: * Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline ...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Novartis AG Sponsored ADR | NVS | 2 | - | Secukinumab |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Pfizer Inc. | PFE | 1 | - | tofacitinib |
Secukinumab is a monoclonal antibody being developed for the treatment of active ankylosing spondylitis, a chronic inflammatory condition affecting the spine and sacroiliac joints. It is supplied as a 150 mg dose in 1.0 mL pre-filled syringes for subcutaneous injection.
Secukinumab targets interleukin-17A (IL17A), a pro-inflammatory cytokine. It acts as an inhibitor of IL17A, which is a monoclonal antibody mechanism. By binding to IL17A, secukinumab is designed to reduce the inflammatory signaling associated with ankylosing spondylitis.
Secukinumab is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the clinical development of this monoclonal antibody for ankylosing spondylitis.
Secukinumab is in Phase 3 clinical development for ankylosing spondylitis. It is an investigational therapy and has not been approved for this indication. The Phase 3 trial has been completed.
Secukinumab has been studied in a Phase 3 trial, NCT02750592, titled "Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis." This completed trial enrolled 30 patients in Japan and was an uncontrolled study without randomization or blinding.