Clinical trial NCT01853033: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
Official title: A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Tolerability
Immunogenicity
Safety
Rheumatoid Arthritis
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-05-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.

Detailed description: This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA) \> 3 months.
* On methotrexate (MTX) therapy =\> 3 months and on a stable dose for at least 4 weeks.
* Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
* Body Mass Index (BMI) is 19 to 38, inclusive.
* Other than RA, subjects should be in good general health.

Exclusion Criteria:

* Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
* History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
* History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
* History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
* Subject has any medical condition or illness other than RA that is not well controlled with treatment.

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
measure: Change in physical exam including vital signs
timeFrame: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
measure: Change in clinical lab test results
timeFrame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
measure: Change in Electrocardiogram (ECG) results
timeFrame: From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
measure: Determination of pharmacokinetic (PK) parameters
timeFrame: Prior to first dose up to 42 days after the last dose of ABT-122
Secondary outcomes:
measure: Measurement of anti-drug anti-bodies (ADA) of ABT-122
timeFrame: Prior to each dose and up until 42 days after the last dose of ABT-122
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Site Reference ID/Investigator# 108655
state: Kansas
city: Raleigh
country: United States
facility: Site Reference ID/Investigator# 107115
state: North Carolina
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 118964
state: Pennsylvania
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 100780
state: Texas
Study officials:
affiliation: AbbVie
name: Robert Padley, MD
role: STUDY_DIRECTOR
References:
citation: Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y.
citation: Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.