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ABT-981 · 3 trials · 4 indications
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.
Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \> 66% of maximum estimated distention (3).
Collect all adverse events at each visit
Blood pressure, heart rate and body temperature
Hematology, Chemistry, and Urinalysis
ECGs done in triplicate
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| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for ABT-981 every two weeks (Q2W) for 24 weeks. |
| ABT-981 | EXPERIMENTAL | ABT-981 200 mg every two weeks (Q2W) for 24 weeks. |
| ABT-981 low dose | EXPERIMENTAL | 25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W) |
| ABT-981 medium dose | EXPERIMENTAL | 100 mg ABT-981 SC E2W |
| ABT-981 high dose | EXPERIMENTAL | 200 mg ABT-981 SC E2W |
| Group 1 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Group 2 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Group 3 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Group 4 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Name | Type | Description |
|---|---|---|
| ABT-981 | BIOLOGICAL | ABT-981 administered by subcutaneous injection |
| Placebo for ABT-981 | BIOLOGICAL | Placebo for ABT-981 administered by subcutaneous injection |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Male or female between the ages of 35 to 80. 2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria 3. Must have radiographic evidence of erosive hand OA 4. Have one or more clinical signs and symptoms of active inflammation in at least ...
ABT-981 is an investigational monoclonal antibody being studied for osteoarthritis, including erosive hand osteoarthritis and knee osteoarthritis. It was developed to treat the signs and symptoms of these musculoskeletal conditions. It has not been approved for any indication and remains in clinical development.
ABT-981 targets interleukin-1 alpha and interleukin-1 beta, two forms of the IL-1 cytokine. It is an interleukin antagonist monoclonal antibody designed to bind and neutralize both IL-1α and IL-1β, which are mediators of inflammation and cartilage degradation in osteoarthritis.
ABT-981 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the clinical trials evaluating the drug in osteoarthritis, including studies in erosive hand osteoarthritis and knee osteoarthritis.
ABT-981 is in Phase 2 clinical development. It has completed a Phase 2a trial in erosive hand osteoarthritis and a Phase 2 trial in knee osteoarthritis, along with an earlier Phase 1 pharmacokinetics study. It is investigational and has not been approved by the FDA.
ABT-981 has been evaluated in three completed trials: NCT02384538, a Phase 2a study in erosive hand osteoarthritis with 132 patients; NCT02087904, a Phase 2 study in knee osteoarthritis with 350 patients; and NCT01668511, a Phase 1 pharmacokinetics study in knee osteoarthritis with 36 patients.
No, ABT-981 is not FDA approved. It is an investigational monoclonal antibody that has completed Phase 2 clinical trials in erosive hand osteoarthritis and knee osteoarthritis. Further clinical development would be required before any potential regulatory approval.