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To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Randomized 7 drug/2 placebo by group |
|
| Group 2 | Experimental | Randomized 7 drug/2 placebo by group |
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| Group 3 | Experimental | Randomized 7 drug/2 placebo by group |
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| Group 4 | Experimental | Randomized 7 drug/2 placebo by group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-981 | Biological | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Collect all adverse events at each visit | From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 |
| Physical Exam including vital signs | Blood pressure, heart rate and body temperature | From date of first dose of ABT-981 until 70 days after last dose of ABT-981 |
| Clinical Lab Testing | Hematology, Chemistry, and Urinalysis | From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 |
| Change from Baseline in Electrocardiogram (ECG) | ECGs done in triplicate | Prior to dose and 8 hours post dose on each day of dosing |
| Maximum observed serum concentration (Cmax) of ABT-981 | Cmax | Prior to first dose up to 70 days after the last dose of ABT-981 |
| Time to Cmax (Tmax) of ABT-981 | Time to Cmax | Prior to first dose up to 70 days after the last dose of ABT-981 |
| The area under the time curve (AUC) of ABT-981 | AUC | Prior to first dose up until 70 days after the last dose of ABT-981 |
| The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of anti-drug anti-bodies (ADA) of ABT-981 | Measurement of ADA | Prior to each dose and up until 70 days after the last dose of ABT-981 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne X. Wang, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 78613 | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28964890 | Result | Wang SX, Abramson SB, Attur M, Karsdal MA, Preston RA, Lozada CJ, Kosloski MP, Hong F, Jiang P, Saltarelli MJ, Hendrickson BA, Medema JK. Safety, tolerability, and pharmacodynamics of an anti-interleukin-1alpha/beta dual variable domain immunoglobulin in patients with osteoarthritis of the knee: a randomized phase 1 study. Osteoarthritis Cartilage. 2017 Dec;25(12):1952-1961. doi: 10.1016/j.joca.2017.09.007. Epub 2017 Sep 28. |
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| Placebo | Biological | Placebo Injection |
|
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 |
| Prior to the last dose up to 70 days after the last dose of ABT-981 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000655035 | lutikizumab |
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