InflammationPhase 2RIGHTNCT05727384
Improving Physical Function in Older Adults Using an Anti-inflammation Drug: The RIGHT Study
A Phase 2 study testing Clazakizumab in people with Inflammation and Frailty, run by Anne B. Newman at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Frailty
- What is being tested?
- Clazakizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 26 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 37Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Health Studies Research Center
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Reducing Inflammation for Greater Health Trial: The RIGHT Study
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.
Read the 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
- Being tested
- Clazakizumab, Placebo
- Medical subject headings
- Inflammation, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClazakizumabDrug
5 mg, subcutaneous injection, every 4 weeks for 24 weeks
PlaceboDrug
5 mg, subcutaneous injection, every 4 weeks for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Clazakizumab | Experimental | Participants received Clazakizumab 5 mg as a subcutaneous injection every 4 weeks for 24 weeks Receives: Drug: Clazakizumab |
| Placebo | Placebo comparator | Participants received Clazakizumab placebo as a 5 mg subcutaneous injection every 4 weeks for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Assess effect of Clazakizumab versus placebo on change of oxygen consumption (VO2 measured as ml/kg/min) with fixed speed walking on treadmill from baseline to 24 weeks
Measured: 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
Assess effect of Clazakizumab versus placebo on change in Short Physical Performance Battery score (0-12 scale, higher score better) from baseline to 24 weeks
Measured: 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
Assess the effect of Clazakizumab versus placebo on change in muscle grip strength (kg) from baseline to 24 weeks
Measured: 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
Assess the effect of Clazakizumab versus placebo on change in Pittsburgh Fatigability Score (0-100 scale, higher score indicates greater mental \& physical fatigue) from baseline to 24 weeks
Measured: 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
Assess the effect of Clazakizumab versus placebo on change in Aortic Pulse Wave Velocity (cm/sec) from baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Peripheral Microvascular Endothelial Function using Peripheral Arterial Tonometry (EndoPat) from baseline to 24 weeks.
Assess the effect of Clazakizumab versus placebo on change in EndoPat derived indices: 1) reactive hyperemia index (RHI is a ratio; higher values indicate greater vessel vasodilator capacity) and 2) augmentation index (AI%; lower values indicate greater vessel elasticity) from baseline to 24 weeks.
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the Montreal Cognitive Assessment (MoCA) from Baseline to 24 Weeks
Assess the effect of Clazakizumab versus placebo on change in the Montreal Cognitive Assessment score (0-30 scale, higher is better) from baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the California Verbal Learning Test (CVLT) from Baseline to 24 Weeks
Assess the effect of Clazakizumab versus placebo on change in the number correct for short word recall and long word recall (0-16 words recalled, each of 5 trials, higher is better), and the number of word intrusions/repetitions using the California Verbal Learning Test from baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the Digit Symbol Substitution Test (DSST) from Baseline to 24 Weeks
Assess the effect of Clazakizumab versus placebo on change in the number correct in 90 seconds (higher is better) on the Digit Symbol Substitution Test from baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the Trails Making B (Trails B) from Baseline to 24 Weeks
Assess the effect of Clazakizumab versus placebo on change in the time to complete (seconds, lower is better) Trails Making Test B from baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Inflammatory Biomarker Interleukin 6 (IL-6) from Baseline to 24 Weeks
Assess the effect of Clazakizumab versus placebo on Interleukin 6 (pg/mL) from Baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Inflammatory Biomarker C-Reactive Protein (CRP) from Baseline to 24 Weeks
Assess the effect of Clazakizumab versus placebo on C-Reactive Protein (mg/dL) from Baseline to 24 weeks
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Assess Safety and Tolerability of Clazakizumab by Monitoring Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline to 44 Weeks
Assess the number of study participants reporting Adverse Events and Severe Adverse Events following the drug injection visits, at the final research assessment visit (24 weeks after baseline), and every 4 weeks for 20 weeks after the final research assessment visit
Measured: AEs and SAEs assessed weekly after randomization/first drug injection visit, one week after drug visits 2-6, at the final research assessment visit (24 weeks after baseline), and every 4 weeks for 20 weeks after the final research assessment visit
Assess Safety and Tolerability of Clazakizumab by Monitoring Safety Laboratory Values From Baseline to 24 Weeks
Compare the percent of participants (Clazakizumab versus placebo) with safety laboratory values for total white blood cell count, absolute neutrophil count, platelet count, liver function (alanine aminotransferase, aspartate aminotransferase and bilirubin, and lipids (total, HDL, and LDL cholesterol and triglycerides) outside of the normal range (as specified in the study protocol) to safely administer the study drug following the drug injection visits, and at the final research assessment visit (24 weeks after baseline).
Measured: assessed weekly after randomization/first drug injection visit, one week after drug visits 2-6, at the final research assessment visit (24 weeks after baseline)
Assess Tolerability of Clazakizumab by Monitoring Adherence to Drug Administration From Baseline to 20 Weeks
Tolerability will be assessed as adherence to the protocol expressed as a percentage of doses received and percentage of drug dosing visits attended in those receiving Clazakizumab versus placebo assessed following each drug injection visit (randomization/first drug injection visit and drug visits 2-6) line).
Measured: Assessed at the time of the drug injection visits from baseline (randomization/first injection) through drug visits 2-6.
Change in Dementia Biomarker Levels from Baseline to 24 Weeks.
Assess the effect of Clazakizumab versus placebo on dementia biomarker levels as measured in peripheral blood, from baseline to 24 weeks. These include 1) Aβ42 and Aβ40 amyloid, 2) phosphorylated tau protein neurofilament light chain, and 3) glial fibrillary acidic protein (all in pg/ml).
Measured: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Aug 2023
- Primary completion5 Jan 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne B. Newman
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor-investigator, Anne B. Newman, University of Pittsburgh
- Investigators
- Anne B. Newman, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727384
- Sponsor's protocol ID
- STUDY19030225
- Acronym
- RIGHT
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data to be shared include clinical characteristics pre-and post-intervention, a data dictionary, and documentation of analytical tools used in data processing (e.g., normalization, unit conversion, etc.).
Publications
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.
PubMed 41518612
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inflammation for Greater Health Trial: The RIGHT Study
- ClinicalTrials.gov ID
- NCT05727384
- Acronym / sponsor ID
- RIGHT / STUDY19030225
- Conditions
- Inflammation, Frailty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Anne B. NewmanUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clazakizumab | Experimental | Drug: ClazakizumabParticipants received Clazakizumab 5 mg as a subcutaneous injection every 4 weeks for 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received Clazakizumab placebo as a 5 mg subcutaneous injection every 4 weeks for 24 weeks |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (37 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clazakizumab5 mg, subcutaneous injection, every 4 weeks for 24 weeks | Drug | Clazakizumab |
| Placebo5 mg, subcutaneous injection, every 4 weeks for 24 weeks | Drug | Placebo |
Primary outcome
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)
Assess effect of Clazakizumab versus placebo on speed of walking 400 meters (meters/second) from baseline to 24 weeks
16 secondary outcomes
Mean Change in Oxygen Consumption While Walking from Baseline to 24 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Peripheral Microvascular Endothelial Function using Peripheral Arterial Tonometry (EndoPat) from baseline to 24 weeks.
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the Montreal Cognitive Assessment (MoCA) from Baseline to 24 Weeks
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the California Verbal Learning Test (CVLT) from Baseline to 24 Weeks
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the Digit Symbol Substitution Test (DSST) from Baseline to 24 Weeks
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Cognitive Function using the Trails Making B (Trails B) from Baseline to 24 Weeks
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Inflammatory Biomarker Interleukin 6 (IL-6) from Baseline to 24 Weeks
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Mean Change in Inflammatory Biomarker C-Reactive Protein (CRP) from Baseline to 24 Weeks
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Assess Safety and Tolerability of Clazakizumab by Monitoring Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline to 44 Weeks
Time frame: AEs and SAEs assessed weekly after randomization/first drug injection visit, one week after drug visits 2-6, at the final research assessment visit (24 weeks after baseline), and every 4 weeks for 20 weeks after the final research assessment visit
Assess Safety and Tolerability of Clazakizumab by Monitoring Safety Laboratory Values From Baseline to 24 Weeks
Time frame: assessed weekly after randomization/first drug injection visit, one week after drug visits 2-6, at the final research assessment visit (24 weeks after baseline)
Assess Tolerability of Clazakizumab by Monitoring Adherence to Drug Administration From Baseline to 20 Weeks
Time frame: Assessed at the time of the drug injection visits from baseline (randomization/first injection) through drug visits 2-6.
Change in Dementia Biomarker Levels from Baseline to 24 Weeks.
Time frame: From baseline (randomization/first drug injection visit) to the final research assessment visit (24 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Derived from this study: PubMed 41518612Sattui 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.
- Individual participant dataSharing planned: Yes. The data to be shared include clinical characteristics pre-and post-intervention, a data dictionary, and documentation of analytical tools used in data processing (e.g., normalization, unit conversion, etc.).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne B. Newman, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clazakizumab in people with Inflammation and Frailty, run by Anne B. Newman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05727384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.