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Small Molecule IRAK4 degrader

KT-474 for Atopic Dermatitis

Phase 1
Waitlist Available
Research Sponsored by Kymera Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 days
Awards & highlights

Study Summary

This trial is testing a new drug, KT-474, for safety, tolerability, and how well it works in patients with atopic dermatitis or hidradenitis suppurativa. They will also study how food affects the absorption of the drug in healthy volunteers.

Eligible Conditions
  • Atopic Dermatitis
  • Hidradenitis Suppurativa
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and frequency of use of concomitant medication
Incidence and severity of treatment emergent Adverse Events
Secondary outcome measures
Apparent clearance (CL/F)
Apparent volume of distribution (Vz/F)
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)] (single dose only)
+7 more
Other outcome measures
IRAK4 levels in peripheral blood mononuclear cells
IRAK4 levels in skin
Percentage Change from baseline in Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (NRS) and Investigator Global Assessment (IGA) in AD patients
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Single ascending dose cohorts in healthy subjectsExperimental Treatment1 Intervention
Healthy volunteer subject cohorts randomized 6:2 receiving a single dose of KT-474 or placebo. The first cohort will receive 25 mg of KT-474 or placebo. Dose escalation will occur if KT-474 or placebo is tolerated.
Group II: Multiple dose cohorts in healthy subjectsExperimental Treatment1 Intervention
Healthy volunteer subject cohorts randomized 9:3 to receive KT-474 or placebo every other day over 14 days, and/or twice weekly over 15 days. The first cohort will receive a dose of KT-474 or placebo determined to be safe based on data generated in the SAD and MAD portion.
Group III: Multiple dose cohort in HS and AD patientsExperimental Treatment1 Intervention
A single cohort of up to 30 patients with AD or HS to receive a dose of KT-474 determined to be safe based on data generated in the healthy volunteer MAD portion, dosed daily X 28 days.
Group IV: Multiple ascending dose cohorts in healthy subjectsExperimental Treatment1 Intervention
Healthy volunteer subject cohorts randomized 9:3 to receive KT-474 or placebo for 14 days continuous dosing. The first cohort will receive a dose of KT-474 or placebo determined to be safe based on data generated in the SAD portion.
Group V: Food Effect Cohort in healthy subjectsExperimental Treatment1 Intervention
Healthy Volunteer SAD subject cohorts (up to 5) will receive a single dose of KT-474 in the fed state.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KT-474/Placebo
2021
Completed Phase 1
~160
KT-474
2021
Completed Phase 1
~160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kymera Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
524 Total Patients Enrolled
Ashwin Gollerkeri, MDStudy DirectorKymera Therapeutics, Inc.
4 Previous Clinical Trials
270 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
TKL Research
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
New York
Recent research and studies
clinicaltrials.govStudy
A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
2021. "A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04772885.
~37 spots leftby Apr 2025
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