Trial Outcomes & Findings for 2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis (NCT NCT05274243)
NCT ID: NCT05274243
Last Updated: 2026-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Baseline to 4 weeks
Results posted on
2026-04-08
Participant Flow
43 patients were screened for eligibility between December 2022 and April 2025 at Vanderbilt University Medical Center.
32 of screen participants were randomized. Of the 11 not randomized, 9 did not meet inclusion criteria and 2 were unable to be recontacted.
Participant milestones
| Measure |
2-HOBA
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
2-HOBA: 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
|
Placebo
Matching placebo (provided as three capsules) three times per day for 4 weeks
Placebo: Placebo (provided as three capsules) three times a day for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
2-HOBA
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
2-HOBA: 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
|
Placebo
Matching placebo (provided as three capsules) three times per day for 4 weeks
Placebo: Placebo (provided as three capsules) three times a day for 4 weeks
|
|---|---|---|
|
Overall Study
Abnormal LFT prior to receiving drug
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
2-HOBA
n=16 Participants
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
2-HOBA: 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
|
Placebo
n=14 Participants
Matching placebo (provided as three capsules) three times per day for 4 weeks
Placebo: Placebo (provided as three capsules) three times a day for 4 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 13 • n=527 Participants
|
56 years
STANDARD_DEVIATION 11 • n=527 Participants
|
54 years
STANDARD_DEVIATION 12 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=527 Participants
|
13 Participants
n=527 Participants
|
26 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
4 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=527 Participants
|
1 Participants
n=527 Participants
|
3 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=527 Participants
|
13 Participants
n=527 Participants
|
27 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=527 Participants
|
3 Participants
n=527 Participants
|
3 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=527 Participants
|
11 Participants
n=527 Participants
|
25 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
1 Participants
n=1054 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=527 Participants
|
14 Participants
n=527 Participants
|
30 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: All participants receiving at least one dose of study drug (modified intent to treat)
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.
Outcome measures
| Measure |
2-HOBA
n=16 Participants
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
2-HOBA: 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
|
Placebo
n=14 Participants
Matching placebo (provided as three capsules) three times per day for 4 weeks
Placebo: Placebo (provided as three capsules) three times a day for 4 weeks
|
|---|---|---|
|
Safety/Tolerability (Adverse Events)
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: Paired week 0 and week 4 cellular isoLG adduct data were available for 21 total participants due to loss of archived cells.
Change in percentage of cellular isoLG adducts will be compared between active and placebo arms.
Outcome measures
| Measure |
2-HOBA
n=11 Participants
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
2-HOBA: 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
|
Placebo
n=10 Participants
Matching placebo (provided as three capsules) three times per day for 4 weeks
Placebo: Placebo (provided as three capsules) three times a day for 4 weeks
|
|---|---|---|
|
Cellular Isolevuglandin (isoLG) Adducts
Week 4
|
13.9 % isolevuglandin positive cells
Standard Deviation 10.6
|
12.7 % isolevuglandin positive cells
Standard Deviation 8.6
|
|
Cellular Isolevuglandin (isoLG) Adducts
Baseline
|
8.8 % isolevuglandin positive cells
Standard Deviation 10.4
|
11.1 % isolevuglandin positive cells
Standard Deviation 8.9
|
Adverse Events
2-HOBA
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2-HOBA
n=16 participants at risk
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
2-HOBA: 2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
|
Placebo
n=14 participants at risk
Matching placebo (provided as three capsules) three times per day for 4 weeks
Placebo: Placebo (provided as three capsules) three times a day for 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
GI upset
|
18.8%
3/16 • Number of events 3 • 4 weeks
|
21.4%
3/14 • Number of events 3 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • 4 weeks
|
7.1%
1/14 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • 4 weeks
|
7.1%
1/14 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
RA flare
|
0.00%
0/16 • 4 weeks
|
7.1%
1/14 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
14.3%
2/14 • Number of events 3 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 2 • 4 weeks
|
7.1%
1/14 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
Numbness (hand)
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
Investigations
Elevated liver function tests (LFTs)
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
7.1%
1/14 • Number of events 1 • 4 weeks
|
|
General disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • 4 weeks
|
0.00%
0/14 • 4 weeks
|
Additional Information
Michelle Ormseth, MD
Vanderbilt University Medical Center
Phone: 615-936-5747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place