NCT02052375

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2408.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jun 2012

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

1.5 years

First QC Date

January 30, 2014

Last Update Submit

February 5, 2014

Conditions

Rheumatoid ArthritisPharmacokinetics of ASP2408

Keywords

Rheumatoid ArthritisASP2408methotrexate

Outcome Measures

Primary Outcomes (5)

  • Pharmacokinetic parameter of ASP2408: AUCtau

    Area Under the Concentration-Time curve for a dosing interval (AUCtau)

    Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141

  • Pharmacokinetic parameter of ASP2408: Cmax

    Maximum Concentration (Cmax)

    Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141

  • Pharmacokinetic parameter of ASP2408: Tmax

    Time to Attain Cmax (Tmax)

    Days 1, 2 ,3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141

  • Pharmacokinetic parameter of ASP2408: Ctrough

    Trough Concentration (Ctrough)

    Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141

  • Safety assessed by adverse events (AEs), laboratory tests, electrocardiograms (ECGs), physical examinations, pulse oximetry, vital signs and Anti-ASP2408 antibody (ADA) formulation

    Up to 1 year

Secondary Outcomes (2)

  • Composite of pharmacokinetics of ASP2408: t1/2, Vz/F, CL/F,

    Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22, 36, 38, 43, 50, 57, 66, 71, 78, 85, 113, 141

  • Pharmacodynamic parameter of ASP2408: CD86 receptor occupancy

    Days 1, 2, 3, 4, 5, 6, 8, 10, 15, 22,36, 38, 43, 50, 57, 66, 71, 72, 78, 85,113, 141

Study Arms (4)

ASP2408 low dosing frequency

EXPERIMENTAL
Drug: ASP2408

ASP2408 high dosing frequency

EXPERIMENTAL
Drug: ASP2408

Placebo low dosing frequency

EXPERIMENTAL
Drug: Placebo

Placebo high dosing frequency

EXPERIMENTAL
Drug: Placebo

Interventions

ASP2408DRUG

subcutaneous injection

ASP2408 high dosing frequencyASP2408 low dosing frequency
PlaceboDRUG

subcutaneous injection

Placebo high dosing frequencyPlacebo low dosing frequency

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject weighs at least 50 kg.
  • Subject has a body mass index (BMI) of ≤ 35 kg/m2.
  • Subject's 12-lead electrocardiogram (ECG) results are normal at Screening and Day 1 prior to study drug dosing or, if abnormal, the abnormality is not clinically significant as determined by the Investigator.
  • Subject has Rheumatoid Arthritis (RA) that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR) ≥ 6 months prior to Screening.
  • Subject meets the ACR 1991 revised criteria for Global Functional Status in RA, Class I, II or III at Screening.
  • Subject MUST be on concomitant methotrexate (MTX):
  • for ≥ 3 months prior to Day 1, AND
  • at a stable dose (10 - 25 mg/week) for ≥ 28 days prior to Day 1 and throughout the study.
  • Subject's other related medications taken for the treatment of RA at the time of Screening must meet the noted stability requirements and remain on a stable regimen, as follows:
  • Non-steroidal anti-inflammatory drugs (NSAIDs), selective cyclooxy-genase-2 (COX-2) inhibitors, oral corticosteroids (≤ 10 mg of prednisone, or equivalent, daily) or low dose opioids (≤ 30 mg of oral morphine, or equivalent, daily) must be stable for ≥ 28 days prior to Screening and remain so throughout the Treatment and Observation Period.
  • Hydroxychloroquine (Plaquenil®) and sulfasalazine must have started ≥ 2 months, and be stable for ≥ 28 days, prior to Day 1.

You may not qualify if:

  • Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to Day 1.
  • Subject has a past history of serious opportunistic infection.
  • Subject has a positive Mantoux tuberculin skin or QuantiFERON-TB Gold test within 90 days of, or at Screening, and has not completed an adequate course of antimicrobial therapy per CDC guidelines.
  • Subject received any live or live-attenuated vaccine within 30 days prior to Day 1.
  • Subject received any of the following:
  • Anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 60 days prior to Day 1.
  • Rituximab (Rituxan®) or any other anti-CD20 antibody within 180 days prior to Day 1.
  • Leflunomide (Arava®) within 60 days prior to drug dosing on Day 1, unless the subject has undergone cholestyramine washout at least 30 days prior to Day 1.
  • Oral or injectable gold, azathioprine, penicillamine, cyclosporine, or tacrolimus within 30 days prior to Day 1.
  • Cyclophosphamide within 180 days prior to Day 1.
  • Subject has received any CTLA4-Ig molecule (including, but not limited to abatacept \[Orencia®\] and belatacept \[Nulojix\]).
  • Subject has participated in a previous clinical study with treatment with ASP2408 or ASP2409 or has participated in another dose cohort of the current trial.
  • Subject has previously participated in any interventional clinical study, or has received an experimental agent within 56 days or 5 half-lives, whichever is longer, prior to Day 1.
  • Subject has a history of prolonged QT syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Metroplex Clinical Research Center, LLC

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ASP2408

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Senior Medical Director

    Astellas Pharma Global Development, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

US(3)