2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

NCT05274243 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 220141
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Safety/Tolerability (Adverse Events)

  Rates of adverse events will be compared between active and placebo arms and presented as summary statistics. Number of participants having an adverse event are reported.

  Baseline to 4 weeks

• Cellular Isolevuglandin (isoLG) Adducts

  Change in percentage of cellular isoLG adducts will be compared between active and placebo arms.

  Baseline to 4 weeks

Study Arms (2)

2-HOBA

EXPERIMENTAL

2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks

Drug: 2-HOBA

Placebo

PLACEBO COMPARATOR

Matching placebo (provided as three capsules) three times per day for 4 weeks

Other: Placebo

Interventions

2-HOBA DRUG

2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks

Also known as: 2-hydroxybenzylamine, salicylamine, IUPAC name: 2-(aminomethyl)phenol

2-HOBA

Placebo OTHER

Placebo (provided as three capsules) three times a day for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

2-(aminomethyl)phenol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Michelle Ormseth, MD
• Organization: Vanderbilt University Medical Center

michelle.ormseth@vumc.org

615-936-5747

Study Officials

• Michelle Ormseth, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: August 9, 2022
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication and for 1 year.
• Access Criteria: Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement. Interested parties may contact the study PI.

Locations

US (1)