A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee

AbbVie

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Biological: ABT-981; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01668511

M12-756

Details and patient eligibility

About

To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female, 40 to 70 years of age, inclusive.
• History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms
• Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3
• Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale
• Other than Osteoarthritis (OA) of the study joint, patient should be in general good health

Exclusion criteria

• Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA
• History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent
• Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint
• Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.
• Any uncontrolled medical illness including unstable treatment or therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

36 participants in 4 patient groups

Group 1

Experimental group

Description:

Randomized 7 drug/2 placebo by group

Treatment:

Biological: Placebo

Biological: ABT-981

Group 2

Experimental group

Description:

Randomized 7 drug/2 placebo by group

Treatment:

Biological: Placebo

Biological: ABT-981

Group 3

Experimental group

Description:

Randomized 7 drug/2 placebo by group

Treatment:

Biological: Placebo

Biological: ABT-981

Group 4

Experimental group

Description:

Randomized 7 drug/2 placebo by group

Treatment:

Biological: Placebo

Biological: ABT-981