A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.

Official Title
-----------------
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects With Erosive Hand Osteoarthritis

Conditions
-----------------
Erosive Hand Osteoarthritis

Intervention / Treatment
-----------------
* Biological: ABT-981
* Biological: Placebo for ABT-981


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between the ages of 35 to 80. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria Must have radiographic evidence of erosive hand OA Have one or more clinical signs and symptoms of active inflammation in at least three hand joints Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6. Exclusion Criteria: Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to Screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, OR current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug. Absolute neutrophil count < 2,000 per mm3 Diagnosis of one or more of the following: Fibromyalgia, Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy, Psoriatic arthritis, psoriasis, Microcrystalline (including gout and pseudo gout) arthritis affecting the hands, Any OA of the hands due to an infectious origin or acute traumatic episode, secondary OA or OA linked to cartilage and bone dysplasia, Other chronic painful syndromes that could interfere with assessment of pain at the hand(s). Any uncontrolled medical illness or an unstable treatment or therapy. Any reason that prohibits a subject to undergo an MRI.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo for ABT-981 every two weeks (Q2W) for 24 weeks. | Biological: Placebo for ABT-981<br>* Placebo for ABT-981 administered by subcutaneous injection<br>|
| Experimental: ABT-981<br>ABT-981 200 mg every two weeks (Q2W) for 24 weeks. | Biological: ABT-981<br>* ABT-981 administered by subcutaneous injection<br>* Other names: lutikizumab;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 | 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. | Week 0 (Baseline), Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | 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. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. | Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 | 
| Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | 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 physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. | Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 | 
| Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | 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 stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. | Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 | 
| Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | 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 total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values. | Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 | 
| Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Participants rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity. | Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 | 
| Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Participants were asked how much they were affected by hand OA by responding to the question Considering all the ways your hand OA affects you, how have you been during the last 48 hours? using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the participant. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the participant. | Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Musculoskeletal diseases, Osteoarthritis, Joint diseases, Rheumatic diseases, Arthritis, Osteoarthritis, Hand