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Also known as GP2017 (adalimumab biosimilar), Adalimumab - GP2017
GP2017 · 1 trial · 1 indication
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...
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 |
GP2017 is an adalimumab biosimilar developed by Novartis AG. It is a monoclonal antibody being studied in immunology, specifically for ankylosing spondylitis. Adalimumab biosimilars are designed as alternatives to the reference adalimumab product, and GP2017 has been evaluated in a Phase 3 clinical trial in patients with ankylosing spondylitis.
GP2017 is being developed for the treatment of ankylosing spondylitis, an inflammatory condition affecting the spine and sacroiliac joints. Its clinical evaluation in this indication was conducted in a Phase 3 study comparing it with secukinumab, with a focus on radiographic progression in patients with ankylosing spondylitis.
GP2017 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the clinical development program for this adalimumab biosimilar in ankylosing spondylitis.
GP2017 is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The completed study was randomized and active controlled, and it enrolled 859 participants with ankylosing spondylitis.
GP2017 has been studied in the Phase 3 trial NCT03259074, titled Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar). The trial enrolled 859 participants aged 18 years and older across the United States, Europe, Asia, Latin America, Australia, and other regions, and it is completed.
GP2017 is also known as GP2017 (adalimumab biosimilar). It is a biosimilar version of adalimumab, a monoclonal antibody, developed by Novartis AG. The two names refer to the same investigational asset being studied in ankylosing spondylitis.