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

NCT05727384 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY19030225
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Frailty

Outcome Measures

Primary Outcomes (1)

• Mean Change in Speed of Walking 400 Meters from Baseline to 24 Weeks

  Assess effect of Clazakizumab versus placebo on speed of walking 400 meters (meters/second) from baseline to 24 weeks

  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)

Secondary Outcomes (16)

• Mean Change in Oxygen Consumption While Walking from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

• Mean Change in Physical Function using the Short Physical Performance Battery (SPPB) Score from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

• Mean Change in Muscle (Grip) Strength from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

• Mean Change in Fatigue Level using the Pittsburgh Fatigability Score (PFS) from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

• Mean Change in Vascular Stiffness using Aortic Pulse Wave Velocity (APWV) from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

Other Outcomes (14)

• Mean Change in Physical Activity Level using the Community Health Activities Model Program for Seniors (CHAMPS) Questionnaire from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

• Mean Change in Physical Activity Level as Assessed by Actigraphy from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

• Mean Change in Quality of Life using the Short Form 36 (SF-36) Health Survey from Baseline to 24 Weeks

  From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)

Study Arms (2)

Clazakizumab

EXPERIMENTAL

Participants received Clazakizumab 5 mg as a subcutaneous injection every 4 weeks for 24 weeks

Drug: Clazakizumab

Placebo

PLACEBO COMPARATOR

Participants received Clazakizumab placebo as a 5 mg subcutaneous injection every 4 weeks for 24 weeks

Drug: Placebo

Interventions

Clazakizumab DRUG

5 mg, subcutaneous injection, every 4 weeks for 24 weeks

Clazakizumab

Placebo DRUG

5 mg, subcutaneous injection, every 4 weeks for 24 weeks

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Persons aged ≥ 70 years at time of randomization
• Gait speed ≥ 0.44 m/sec to \< 1.0 m/sec or BMI ≥ 28 kg/m2
• IL-6 level ≥ 2.0 pg/ml but \< 30.0 pg/ml
• Self-reported difficulty walking ¼ mile or climbing 10 steps
• Self-reported ability to walk 400 meters (about 2-3 blocks), unassisted
• Self-reported vaccinations for COVID-19, Influenza and pneumococcal pneumonia up to date per current CDC guidelines

You may not qualify if:

• Advanced neurologic disorder such as dementia, Parkinson's disease, amytrophic lateral sclerosis, or multiple sclerosis that would impact the ability to improve on functional assessments
• Resident in a nursing home
• Severe hearing or vision loss that would impair participant's ability to complete questionnaires or follow oral instructions, and which may limit feasibility of performing functional assessments
• Acute infections (including but not limited to common cold virus, shingles virus, bronchitis, skin infection, urinary tract infection, tooth abscess) within 60 days of randomization
• Chronic infection (including but not limited to):
• History of active TB or evidence of latent TB based on a positive PPD skin test, positive Quantiferon TB-Gold test, or a history of old or latent TB on chest x-ray
• History of Hepatitis B or Hepatitis C
• Previous diagnosis of Human Immunodeficiency Virus (HIV) or Acquired ImmunoDeficiency Syndrome (AIDS)
• Inflammatory or autoimmune disease (including but not limited to rheumatoid arthritis, lupus, or inflammatory bowel disease, such as ulcerative colitis or Crohn's disease)
• Immunization with a live/attenuated vaccine within 2 months prior to randomization (e.g., viral: measles vaccine, mumps vaccine, rubella vaccine, live attenuated influenza vaccine, live attenuated chicken pox or shingles vaccine, smallpox vaccine, oral polio vaccine (Sabin), rotavirus vaccine, and yellow fever vaccine. Bacterial: BCG vaccine, oral typhoid vaccine and epidemic typhus vaccine)
• Current use of chronic immune modulating medications such as corticosteroids, monoclonal antibodies, janus kinase inhibitors, calcineurin inhibitors, mTOR inhibitors, IMDH inhibitors, or biologics
• Admitted for an overnight hospitalization in the last 6 months
• Open-chest heart surgery (including, but not limited to, coronary artery bypass graft surgery or aortic valve surgery) in the past 6 months
• Anticipating major surgery (including, but not limited to, chest, abdomen, or joint surgery) in the next 6 months
• Deep vein thrombosis or pulmonary embolus in the past 6 months

Sponsors & Collaborators

• Anne B. Newman: lead
• CSL Behring: collaborator

Study Sites (1)

University of Pittsburgh, Health Studies Research Center

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Sattui SE, Bertolet M, Forman DE, Danielson ME, Yao S, Lopez OL, Glynn NW, Nadkarni NK, Sekikawa A, Bruno TC, Finkel T, Newman AB. The "Reducing Inflammation for Greater Health Trial (RIGHT)" Study-Concept, Rationale, and Design. J Am Geriatr Soc. 2026 Mar;74(3):636-647. doi: 10.1111/jgs.70272. Epub 2026 Jan 10.

  PMID: 41518612 DERIVED

MeSH Terms

Conditions

Inflammation; Frailty

Interventions

clazakizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne B. Newman, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: August 1, 2023
• Primary Completion: January 5, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available approximately 6 months after the study describing the data is accepted for publication (seminal publication). The data will be made available for an indefinite period of time to be determined by the study Principal Investigator.
• Access Criteria: All individuals will be required to enter into a Data Use Agreement that a) acknowledges that the data will be stripped of identifying markers and unusual characteristics that might provide identification, (b) acknowledge that these data will only be used for research purposes, and (c) assure that the investigator will either destroy the raw data or return it to Dr. Newman (Study PI) when their research has been completed. Individuals will also be required to reference the seminal publication describing the data collection and acknowledge the source of funding.

Locations

US (1)