2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Phase 2 trial tests 2-HOBA for Rheumatoid Arthritis patients
Plain English Summary
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis is a Phase 2 clinical trial sponsored by Vanderbilt University Medical Center studying Rheumatoid Arthritis. This study tests a new drug called 2-HOBA to see if it's safe and how well it works for rheumatoid arthritis. It is for adults with rheumatoid arthritis who meet specific joint and medication criteria. Participants will take either 2-HOBA or a placebo for 4 weeks, with regular check-ups. Standard treatments for rheumatoid arthritis include disease-modifying antirheumatic drugs (DMARDs) and other medications. The trial aims to enroll 32 participants.
Official Summary
This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks. As primary outcome measures investigators will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes investigators will compare changes in markers of inflammation, DAS28 score, and 24-hour blood pressure in active and placebo arms. This pilot study will inform the feasibility and design of future studies to examine the efficacy of 2-HOBA in RA patients.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of rheumatoid arthritis. Must have at least 4 tender or swollen joints. Cannot have active cancer (except certain skin cancers), active infections, or other autoimmune diseases. Women of childbearing potential must agree to use effective birth control. This trial is studying Rheumatoid Arthritis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe the drug is by tracking side effects and whether it reduces specific markers in the blood related to inflammation. The specific primary outcome measures are: Safety/Tolerability (Adverse Events) (Baseline to 4 weeks); Cellular Isolevuglandin (isoLG) Adducts (Baseline to 4 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial is important because it explores a new treatment option for rheumatoid arthritis, aiming to reduce inflammation and its effects. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Rheumatoid Arthritis, where improved treatment options are needed.
Investor Insight
This is an early-stage trial for a novel drug, indicating potential for a new treatment in the large rheumatoid arthritis market, though success is not guaranteed. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of 2-HOBA compared to your current treatment. Understand that you will be randomly assigned to receive either the study drug or a placebo. Be prepared for regular visits to monitor your health and any potential side effects. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 32 participants
Interventions
- DRUG: 2-HOBA — 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
- OTHER: Placebo — Placebo (provided as three capsules) three times a day for 4 weeks
Primary Outcomes
- Safety/Tolerability (Adverse Events) (Baseline to 4 weeks)
- Cellular Isolevuglandin (isoLG) Adducts (Baseline to 4 weeks)
Full Eligibility Criteria
Inclusion Criteria: * Written informed consent * Age ≥18 years * Meets 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid Arthritis classification criteria * ≥ 4 tender or swollen joints * No change in DMARDs, glucocorticoids in ≥ 4 weeks * If of childbearing potential, willingness to use effective birth throughout study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device) * If using non-steroidal anti-inflammatory drugs (NSAIDs), willingness to discontinue use of NSAIDs for 2 weeks prior to the study and throughout the study Exclusion Criteria: * Pregnant or breastfeeding * Active cancer except non-melanoma skin cancer * Active infection * Concomitant inflammatory autoimmune disease * Major surgery in ≤ 3 months * Aspirin allergy * Use of MAO-I * Estimated creatinine clearance \<30 ml/min * Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \>1.5x the upper limit of normal or total bilirubin ≥1.5 mg/dl
Trial Locations
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
Frequently Asked Questions
What is clinical trial NCT05274243?
NCT05274243 is a Phase 2 INTERVENTIONAL study titled "2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis." It is currently completed and is sponsored by Vanderbilt University Medical Center. The trial targets enrollment of 32 participants.
What conditions does NCT05274243 study?
This trial investigates treatments for Rheumatoid Arthritis. The primary condition under study is Rheumatoid Arthritis.
What treatments are being tested in NCT05274243?
The interventions being studied include: 2-HOBA (DRUG), Placebo (OTHER). 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
What does Phase 2 mean for NCT05274243?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT05274243?
This trial is currently "Completed." It started on 2022-08-09. The estimated completion date is 2025-05-28.
Who is sponsoring NCT05274243?
NCT05274243 is sponsored by Vanderbilt University Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05274243?
The trial aims to enroll 32 participants. The trial status is completed.
How is NCT05274243 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05274243?
The primary outcome measures are: Safety/Tolerability (Adverse Events) (Baseline to 4 weeks); Cellular Isolevuglandin (isoLG) Adducts (Baseline to 4 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05274243 being conducted?
This trial is being conducted at 1 site, including Nashville, Tennessee (United States).
Where can I find official information about NCT05274243?
The official record for NCT05274243 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05274243. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05274243 testing in simple terms?
This study tests a new drug called 2-HOBA to see if it's safe and how well it works for rheumatoid arthritis. It is for adults with rheumatoid arthritis who meet specific joint and medication criteria.
Why is this trial significant?
This trial is important because it explores a new treatment option for rheumatoid arthritis, aiming to reduce inflammation and its effects.
What are the potential risks of participating in NCT05274243?
The most common risks are related to tolerability and potential side effects, which will be closely monitored. Specific risks include potential adverse events that are typical for new drug studies. Participants with certain kidney or liver function issues may not be eligible. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05274243?
Ask your doctor about the potential benefits and risks of 2-HOBA compared to your current treatment. Understand that you will be randomly assigned to receive either the study drug or a placebo. Be prepared for regular visits to monitor your health and any potential side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05274243 signal from an investment perspective?
This is an early-stage trial for a novel drug, indicating potential for a new treatment in the large rheumatoid arthritis market, though success is not guaranteed. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will take either 2-HOBA or a placebo for 4 weeks, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.