A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531178
• Other study ID #: M14-439
• Secondary ID: 2015-000094-12
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2015
• Last updated: March 1, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of methotrexate weekly throughout participation in the study.

This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2 subjects will receive placebo. Subjects participating in one dose group will be ineligible to participate in another dose group in the study.

Description:

Multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Rheumatoid Arthritis based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria, or ACR 1987 for patients with diagnosis prior 2011 = 3 months.

• Except for methotrexate (MTX), the subject must have discontinued all disease modifying anti-rheumatic drugs (DMARD) for at least 5 half-lives before the first dose of study drug, and undergone cholestyramine washout if received Leflunomide within the past 3 months.

• Subject must have been on MTX therapy > 3 months and on a stable dose (7.5 - 25 mg/week), for at least 4 weeks prior to the first dose of study drug. Subject must be able to continue on stable dose of MTX for the duration of study participation.

• Body Mass Index (BMI) is 19 to 35, inclusive. (BMI is calculated as weight [kg] divided by height [m2].)

• Judged to be in good general health as determined by the Investigator based upon the results of medical history, laboratory profile, physical examination and 12-lead electrocardiogram (ECG) performed at screening

Exclusion Criteria:

• Evidence of anti-ABBV-257 antibody results in a pre-study serum sample.

• History of significant allergic reaction or significant sensitivity to any constituents of the study drug; or history of anaphylactic reaction to any agent (e.g., food products and bee sting); or history of a major reaction to any Immunoglobulin G (IgG) containing product.

• History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral antimicrobials/antibiotics within 30 days prior to initial study drug administration.

• History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.

• Clinically significant abnormal screening laboratory results as evaluated by the Investigator, including serum values of Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) greater than 2.25 × the upper limit of normal, or creatinine greater than 1.5 × the upper limit of normal, or absolute neutrophil count < 1500 µ/L.

• Subject has any medical condition or illness other than RA that is not well controlled with treatment that would, in the opinion of the investigator, preclude study participation or interfere with other symptoms of Rheumatoid Arthritis (RA).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• ABBV-257
subcutaneous injection
• Placebo
Placebo for ABBV-257

Locations

Country	Name	City	State
Germany	Site Reference ID/Investigator# 139394	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	American College of Rheumatology (ACR) 20 response rate	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	Up to day 193	No
Other	American College of Rheumatology (ACR) 50 response rate	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	Up to day 193	No
Other	American College of Rheumatology (ACR) 70 response rate	ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.	Up to day 193	No
Other	Change in Disease Activity Score 28	Calculated from tender joint, swollen joint and high sensitive C-reactive protein	From day 1 to day 193	No
Primary	Proportion of subjects with adverse events	This will be collected through out the study	Up to day 193	Yes
Primary	Change in Vital signs	Vital signs including blood pressure and heart rate will be assessed	From day 1 to day 193	Yes
Primary	Change in Physical examination	Changes in any physical exam assessed by the physician will be assessed.	From day 1 to day 193	Yes
Primary	Changes in Electrocardiogram (ECG)	ECG measurements will be assessed	From day 1 to day 193	Yes
Primary	Maximum observed serum concentration (Cmax)	This will be assessed using non-compartmental methods.	Up to day 50	No
Primary	Time to maximum observed serum concentration (Tmax)	This will be assessed using non-compartmental methods.	Up to day 50	No
Secondary	Immunogenicity by measurement of Anti-drug antibody	Immunogenicity will be measured to see if the body has produced an immune response to ABBV-257	Up to day 193	No