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Monoclonal Antibodies
Clazakizumab for Frailty (RIGHT Trial)
Phase 2
Recruiting
Led By Anne B. Newman, MD, MPH
Research Sponsored by Anne B. Newman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
RIGHT Trial Summary
This trial will test if a drug can reduce inflammation & improve mobility & disability in older adults. They'll receive injections & tests to assess physical, cognitive & immune function & have blood samples collected. Comparisons between drug & placebo groups will be made.
Who is the study for?
The RIGHT Study is for people aged 70 or older with certain levels of inflammation in their blood, up-to-date vaccinations, and difficulty walking but able to walk unassisted. Excluded are those living in nursing homes, with severe sensory loss, chronic infections like TB or hepatitis, recent hospitalizations, serious heart/lung disease requiring oxygen, uncontrolled diabetes/cancer history, abnormal lab results (blood counts/cholesterol), allergies to monoclonal antibodies, on blood thinners or immune modulators.Check my eligibility
What is being tested?
This trial tests Clazakizumab against a placebo to see if it can improve walking speed and reduce inflammation markers in the elderly. Participants will receive injections every four weeks for six months and undergo various physical function tests along with cognitive assessments and blood sample collections for immune function analysis.See study design
What are the potential side effects?
Potential side effects from Clazakizumab may include reactions at the injection site such as pain or swelling; increased risk of infections due to immune system suppression; possible changes in liver enzymes indicated by blood tests; fatigue; allergic reactions.
RIGHT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Change in Speed of Walking 400 Meters from Baseline to 24 Weeks
Secondary outcome measures
Assess Safety and Tolerability of Clazakizumab by Monitoring Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline to 44 Weeks
Assess Safety and Tolerability of Clazakizumab by Monitoring Safety Laboratory Values From Baseline to 24 Weeks
Assess Tolerability of Clazakizumab by Monitoring Adherence to Drug Administration From Baseline to 20 Weeks
+12 moreOther outcome measures
Change in CD-8 T Cell Function from Baseline to 24 Weeks
Change in Counts of Immune B Cell, T Cell and Memory B Cell Subsets from Baseline to 24 Weeks
Change in Frequency of Immune B Cell, T Cell and Memory B Cell Subsets from Baseline to 24 Weeks
+7 moreSide effects data
From 2015 Phase 2 trial • 143 Patients • NCT020155208%
LEUKOPENIA
8%
INJECTION SITE REACTION
8%
NEUTROPENIA
5%
DYSLIPIDAEMIA
5%
ALANINE AMINOTRANSFERASE INCREASED
3%
TOOTH INFECTION
3%
ABDOMINAL PAIN
3%
DENTAL CARIES
3%
IRRITABLE BOWEL SYNDROME
3%
VIRAL INFECTION
3%
LABYRINTHITIS
3%
NASOPHARYNGITIS
3%
BRONCHITIS
3%
UPPER RESPIRATORY TRACT INFECTION
3%
DIZZINESS
3%
GASTROENTERITIS VIRAL
3%
HERPES ZOSTER
3%
SKIN CANDIDA
3%
JOINT INJURY
3%
LACERATION
3%
DIABETES MELLITUS
3%
TENSION HEADACHE
3%
EOSINOPHILIA
3%
THROMBOCYTOPENIA
3%
RASH VESICULAR
3%
HEPATIC STEATOSIS
3%
EAR PAIN
3%
TINNITUS
3%
INJECTION SITE ERYTHEMA
3%
INJECTION SITE PRURITUS
3%
STOMATITIS
3%
BLOOD CHOLESTEROL INCREASED
3%
RHINITIS ALLERGIC
3%
THROAT IRRITATION
3%
HEPATIC FUNCTION ABNORMAL
3%
VULVOVAGINAL DISCOMFORT
3%
INJECTION SITE VESICLES
3%
INJECTION SITE RASH
3%
HEPATIC ENZYME INCREASED
3%
URINARY TRACT INFECTION
3%
LIMB INJURY
3%
SKIN HYPERPIGMENTATION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clazakizumab (25 mg) + MTX
Clazakizumab (1 mg) + MTX
Clazakizumab (5 mg) + MTX
Placebo + Methotrexate (MTX)
RIGHT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClazakizumabExperimental Treatment1 Intervention
Participants received Clazakizumab 5 mg as a subcutaneous injection every 4 weeks for 24 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants received Clazakizumab placebo as a 5 mg subcutaneous injection every 4 weeks for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clazakizumab
2012
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
CSL BehringIndustry Sponsor
194 Previous Clinical Trials
1,211,162 Total Patients Enrolled
Anne B. NewmanLead Sponsor
Anne B. Newman, MD, MPHPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before.I am currently taking Warfarin.I have not had any serious infections in the last 2 months.I am currently taking medication that affects my immune system.My walking speed is between slow and moderate.I have a severe neurological condition like dementia or MS.I have had a blood clot in my leg or lung in the last 6 months.I have not received a live vaccine in the last 2 months.I have recently been hospitalized or had open-chest surgery.I need oxygen due to severe lung or heart disease.I have had diverticular disease or a GI perforation.I am 70 years old or older.I struggle to walk ¼ mile or climb 10 steps.I can walk 400 meters by myself.I do not have chronic infections like TB, Hepatitis B/C, or HIV/AIDS.I have severe hearing or vision loss that makes it hard for me to follow instructions or fill out forms.
Research Study Groups:
This trial has the following groups:- Group 1: Clazakizumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does Clazakizumab pose a risk to individuals?
"Our evaluation at Power rated the safety of Clazakizumab a 2, since this is only a Phase 2 trial. While there is existing information surrounding its safety profile, no data exists to suggest efficacy."
Answered by AI
Is this research opportunity accessible to people seeking treatment?
"Clinicaltrials.gov indicates that this medical study, which originally opened on March 1st 2023 and was last updated February 3rd 2023, is not currently recruiting patients. However, there are still 477 other clinical trials in search of participants at the moment."
Answered by AI
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