Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03259074 | Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) | PHASE3 | COMPLETED | 859 | — | — | Nov 30, 2017 | Nov 29, 2021 | Aug 21, 2023 | 171 | United States, Argentina +27 |
Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.
| Arm | Type | Description |
|---|---|---|
| AIN457 150 mg/placebo | EXPERIMENTAL | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
| AIN457 300 mg | EXPERIMENTAL | AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
| GP2017 40mg | ACTIVE_COMPARATOR | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102 |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes |
| GP2017 (adalimumab biosimilar) | BIOLOGICAL | 40 mg in pre-filled syringes was administered subcutaneously |
| AIN457 150 mg | BIOLOGICAL | 150 mg in pre-filled syringes was administered subcutaneously |
Inclusion Criteria: * Male or non-pregnant, non-nursing female patients at least 18 years of age * Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic D...
| 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 |
| AbbVie, Inc. | ABBV | 1 | — | Upadacitinib |
| Pfizer Inc. | PFE | 1 | — | Tofacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | — | Secukinumab |
| TScan Therapeutics, Inc. | TCRX | 1 | — | Undisclosed |