Improving Physical Function in Older Adults Using an Anti-inflammation Drug: The RIGHT Study

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Anne B. Newman
Study ID
NCT05727384
Phase
PHASE2
Status
Completed

Conditions

  • Frailty
  • Inflammation

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clazakizumab — DRUG
    5 mg, subcutaneous injection, every 4 weeks for 24 weeks
  • Placebo — DRUG
    5 mg, subcutaneous injection, every 4 weeks for 24 weeks

Study Details

The goal of this clinical trial is to learn about the effects of inflammation-lowering therapy on mobility and disability in older adults. The main questions it aims to answer are: * Will therapy improve walking speed/pace? * Will therapy improve levels of blood inflammation markers and other indicators of physical, cognitive and immune function? Participants will be asked to receive injections of drug or placebo every 4 weeks for 24 weeks. They will also be asked to undergo testing that assesses physical function, thinking ability and brain health, breathing capacity, and blood vessel stiffness, and will have blood samples collected to measure immune function and to create a bank of samples for future testing. Comparisons will be made between those who receive drug and those who receive placebo.

Key Dates

Start date
Aug 1, 2023
Status verified
Jun 2026
Primary completion
Jan 5, 2026
Completion
May 26, 2026

Study Design

Enrollment
29 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clazakizumab
    Participants received Clazakizumab 5 mg as a subcutaneous injection every 4 weeks for 24 weeks
  • Placebo Comparator: Placebo
    Participants received Clazakizumab placebo as a 5 mg subcutaneous injection every 4 weeks for 24 weeks

Primary Outcome Measure

Mean Change in Speed of Walking 400 Meters from Baseline to 24 Weeks [ Time Frame: From enrollment (randomization/first drug injection visit) to the final research assessment visit (4 weeks after final drug injection visit or 24 weeks after enrollment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh, Health Studies Research CenterPittsburghPennsylvania15260-

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University of Pittsburgh, Health Studies Research Center· Pittsburgh, PA

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