Improving mobility in older adults with an anti-inflammation drug
Reducing Inflammation for Greater Health Trial: The RIGHT Study
This study is testing if an anti-inflammation drug called clazakizumab can help older adults aged 70 and above walk better and improve their overall mobility.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | clazakizumab |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05727384 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of clazakizumab, an inflammation-lowering therapy, on mobility and disability in older adults aged 70 and above. Participants will receive either the drug or a placebo every four weeks for six months, during which their walking speed, physical function, cognitive ability, and various health markers will be assessed. The study will involve a series of tests, including a 400-meter walk, blood samples, and assessments of breathing capacity and blood vessel stiffness. The primary goal is to determine if clazakizumab can significantly improve walking speed compared to placebo.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 70 and older with mildly elevated IL-6 levels and self-reported difficulty in walking or climbing stairs.
Not a fit: Patients with advanced neurological disorders, severe sensory impairments, or those residing in nursing homes may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could enhance mobility and overall physical function in older adults, potentially reducing frailty and improving quality of life.
How similar studies have performed: Other studies have shown promise in using anti-inflammatory therapies for improving physical function in older adults, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Severe lung disease or heart disease that requires oxygen use anytime during the day (including, but not limited to, use only during activity, use only at night or use all day) * Tobacco use (including cigarettes, cigar, pipe, or vaping) or inhaled cannabis in the past 6 months * Current consumption of \> 14 alcoholic drinks per week * History of substance abuse including cocaine, methamphetamine, opioids, or narcotics; any use of cannabis * Uncontrolled diabetes, noncompliant with treatment or fasting glucose \> 250 mg/dL * Cancer: Stage 1 cancer (including melanoma skin cancers) within the past 5 years, other than adequately treated (fully excised and recovered from surgery based on the judgement of a study MD) basal and/or squamous cell skin cancer, or stage 2 or stage 3 cancer within 10 years, or any history of stage 4 (metastatic) cancer * Inability to get a normal systolic blood pressure reading (between 100-180) at two consecutive visits prior to randomization (must be at least 1 day apart) * ALT, AST, or Total Bilirubin \> Upper Limit of Normal (ULN) * Absolute Neutrophil Count outside normal range or \< 1.5 x109/L * White Blood Count outside normal range * Platelet count outside normal range or \< 125 x109/L * Hemoglobin \<10 g/dL * Total Cholesterol \> 300 mg/dL or Triglycerides \> 400 mg/dL * Dialysis treatment or chronic renal insufficiency defined as CKD-EPI eGFR \< 25 ml/min/(1.73) m2 * History of diverticular disease or GI perforation * History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * Current use of Warfarin (Coumadin, Jantoven) * Unable or unwilling to provide informed consent * Current participation in another interventional study (including trials of exercise, diet, or investigational drugs) * A psychiatric disorder that is impairing ability to consent or comply with requirements of the trial * Residence or travel outside of the study area for more than one month during the study or planning to move out of the area in the next six months. * Other conditions which at the discretion of a study physician investigator which would make participation unsafe or inappropriate (logistic, behavioral, medical)
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh, Health Studies Research Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Anne B. Newman, MD, MPH — University of Pittsburgh
- Study coordinator: Kim Lucas
- Email: klucas@pitt.edu
- Phone: (412) 624-3579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.