New antibody drug takes aim at rheumatoid arthritis in first human trial
NCT ID NCT07564154
First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 5 times
Summary
This early-stage trial tests a new drug called KT502 in 27 adults with moderate to severe rheumatoid arthritis. The drug is designed to deplete certain immune cells (B cells) that contribute to joint inflammation. The main goal is to check safety and find the right dose, not yet to see if it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KT502 (a monoclonal antibody that targets and depletes B cells)
- What this could lead to
- If successful, this could lead to a new treatment option for rheumatoid arthritis that helps control the disease by targeting immune cells.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, not effectiveness. The drug may cause side effects like cytokine release syndrome, and it may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion: 1. 18 to 75 years old 2. Diagnosis of adult-onset RA for at least 6 months 3. Moderately to severely active RA 4. Inadequate treatment response as defined in the protocol 5. RF + or ACPA+ 6. Stable use of traditional DMARDs is permitted 7. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions. Exclusion: 1. Functional class IV as defined by the ACR Classification of Functional Status in RA 2. Presence of any concomitant autoimmune disease other than RA 3. Active infection, history of serious recurrent or chronic infection 4. History of progressive multifocal leukoencephalopathy 5. Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years. 6. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation 7. Receipt of live vaccine within 4 weeks 8. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study 9. Women who are pregnant or breastfeeding 10. Significant or uncontrolled medical disease that would preclude participant participation
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Rheumatoid arthritis (RA) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Kali Therapeutics Trial Site
RECRUITINGBayswater, Victoria, Australia
Contact Email: •••••@•••••
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Kali Therapeutics Trial Site
RECRUITINGAuckland, NZ, New Zealand
Contact Email: •••••@•••••
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- Heart risk in rheumatoid arthritis: could a blood vessel drug help?