KT502 for Rheumatoid Arthritis

A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)

Recruiting Phase 1 Interventional Study
Rheumatoid Arthritis (RA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
27 (estimated)
Sponsor
Kali Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for adults between 18 and 75 years old with rheumatoid arthritis. Participants will receive KT502 injections to help researchers study its safety and how it works in the body.

Are You a Good Fit for This Trial?
Rules you out PregnancyBreastfeeding

You may be able to join if

  • I am between 18 to 75 years old.
  • I have been diagnosed with rheumatoid arthritis for at least 6 months.
  • I have moderately to severely active rheumatoid arthritis.
  • My rheumatoid arthritis treatment has not been effective.
  • I have tested positive for rheumatoid factor or ACPA.
  • I am currently stable on traditional RA medications.
  • I am willing and able to follow the study rules and schedule.

You may not be able to join if

  • I am classified as functional class IV for rheumatoid arthritis.
  • I have another autoimmune disease besides rheumatoid arthritis.
  • I currently have an active infection or a history of serious infections.
  • I have a history of progressive multifocal leukoencephalopathy.
  • I have had cancer in the last 5 years or breast cancer within the last 10 years.
  • I have had or planned to have an organ transplant.
  • I received a live vaccine within the last 4 weeks.
  • I have had major surgery in the last 8 weeks or plan to have major surgery in the next 6 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT502 administered subcutaneously to participants with Rheumatoid Arthritis (RA). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.

Trial Locations
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Eligibility Criteria
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 assess…
Contacts

Trial Information

1-858-888-3080

clinical@kalitherapeutics.com

CONTACT