NCT05727384

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

Reducing Inflammation for Greater Health Trial: The RIGHT Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Anne B. Newman · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The primary objective of this trial is to assess the impact of inflammation-lowering therapy with clazakizumab 5 mg/month on speed when walking 400 meters in older adults. The investigators hypothesize that participants treated with clazakizumab will see a larger 6-month improvement in their pace on a 400-meter walk than those provided placebo. The aims of the study will be to: * To test the effect of clazakizumab 5 mg/month for 6 months on walking speed during a 400- meter corridor walk in adults 70 years of age and older with baseline levels of IL-6 ≥ 2.0 pg/ml and \< 30 pg/ml * To assess the effect of clazakizumab 5 mg/month on serum levels of free interleukin (IL-6), circulating C-reactive protein (CRP), and other inflammatory markers * To assess the effect of clazakizumab 5 mg/month on oxygen utilization (VO2) during submaximal steady-state walking in adults 70 years of age and older with baseline levels of IL-6 ≥ 2.0 pg/ml and \< 30 pg/ml, physical function, physical activity, perceived fatigability (overall, by questionnaire and in association with preferred and fixed speed walking), cognition, body weight, blood pressure, vascular stiffness, endothelial function, kidney function and immune function * To determine the safety and tolerability of clazakizumab 5 mg/month This study will randomize 60 community living men and women 70 years of age and older who have mildly elevated IL-6 at baseline (≥ 2.0 pg/ml and \< 30.0 pg/ml). Interested individuals will undergo telephone and in-person screening visits (two) to determine eligibility (blood will be collected to measure IL-6, height and weight will be measured, a 4m walk test will be administered to determine gait speed, and a review of medical history, medications, a physical exam, and blood safety labs will be conducted to ensure safety to proceed/eligibility). Randomization to study drug or placebo will take place within 60 days of the first in-person screening visit and subsequent injections will take place every 4 weeks for 24 weeks. Participants will undergo physical function testing (400m walk, preferred \& fixed speed walk on a treadmill with oxygen consumption measurement, short physical performance battery, grip strength, actigraphy), cognitive testing, and aortic pulse wave velocity and endothelial function testing. Height, weight and pulse will be measured. Participants will complete questionnaires to assess demographics, physical activity level, fatigability, sleep quality, pain and depression. Blood will be collected/processed to measure immune function and stored frozen to create a biorepository of samples (serum, plasma, buffy coat) for future testing. Participants will be monitored for safety in between injection visits and for 5 months following the final in-person research visit.

Conditions

• Inflammation
• Frailty

Interventions

Type	Name	Description
DRUG	Clazakizumab	5 mg, subcutaneous injection, every 4 weeks for 24 weeks
DRUG	Placebo	5 mg, subcutaneous injection, every 4 weeks for 24 weeks

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-01-05
• Completion: 2026-07-01
• First posted: 2023-02-14
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study