Trials Sponsors Conditions Drugs Pricing

Conditions

Atopic Dermatitis Healthy Volunteer Hidradenitis Suppurativa

Keywords

Atopic DermatitisHidradenitis SuppurativaImmune-inflammatory diseases

Outcome Measures

Primary Outcomes (2)

Incidence and severity of treatment emergent Adverse Events
up to 28 days
Incidence and frequency of use of concomitant medication
up to 28 days

Secondary Outcomes (10)

Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)] (single dose only)
up to 28 days
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
up to 28 days
Area under the plasma concentration-time curve during a dosing interval [AUC(0-tau)]
up to 28 days
Maximum observed plasma concentration (Cmax)
up to 28 days
Time to maximum observed plasma concentration (Tmax)
up to 28 days
+5 more secondary outcomes

Other Outcomes (4)

IRAK4 levels in peripheral blood mononuclear cells
up to 28 days
IRAK4 levels in skin
up to 28 days
Percentage Change from baseline in Total Abscess and Inflammatory Nodule (AN) Count, Skin Pain Numerical Rating Scale (NRS), Peak pruritis NRS, and HS Physician's Global Assessment (HS-PGA) in HS patients
up to 42 days
+1 more other outcomes

Study Arms (5)

Single ascending dose cohorts in healthy subjects

EXPERIMENTAL

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.

Drug: KT-474/Placebo

Multiple ascending dose cohorts in healthy subjects

EXPERIMENTAL

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.

Drug: KT-474/Placebo

Food Effect Cohort in healthy subjects

EXPERIMENTAL

Interventions

KT-474/PlaceboDrug

KT-474 or matching placebo oral tablet(s)

Food Effect Cohort in healthy subjectsMultiple ascending dose cohorts in healthy subjectsMultiple dose cohorts in healthy subjectsSingle ascending dose cohorts in healthy subjects

KT-474Drug

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male and female subjects, including female subjects of child bearing potential, between the ages of 18 and 55 with a weight at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2.
Subjects confirmed as negative in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection test at Screening and on Day -2.

Sponsors & Collaborators

Kymera Therapeutics, Inc.
Industrylead

Study Sites (14)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Southwest Skin Specialists 32nd St

Phoenix, Arizona, 85018, United States

Southwest Skin Specialists Tatum

Phoenix, Arizona, 85028, United States

Beatrice Keller Clinic

Sun City West, Arizona, 85375, United States

Encore Medical Research, LLC. - Boynton Beach

Boynton Beach, Florida, 33436, United States

Research Centers of America

Hollywood, Florida, 22024, United States

Encore Medical Research, LLC. - Hollywood

Related Publications (2)

Agarwal S, McDonald AA, Campbell V, Chen D, Davis J, Rong H, Mishkin A, Slavin A, Gollerkeri A, Gollob JA. Pharmacokinetics and Pharmacodynamics of KT-474, a Novel Selective Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) Degrader, in Healthy Adults. Clin Transl Sci. 2025 Mar;18(3):e70181. doi: 10.1111/cts.70181.
PMID: 40055981DERIVED
Ackerman L, Acloque G, Bacchelli S, Schwartz H, Feinstein BJ, La Stella P, Alavi A, Gollerkeri A, Davis J, Campbell V, McDonald A, Agarwal S, Karnik R, Shi K, Mishkin A, Culbertson J, Klaus C, Enerson B, Massa V, Kuhn E, Sharma K, Keaney E, Barnes R, Chen D, Zheng X, Rong H, Sabesan V, Ho C, Mainolfi N, Slavin A, Gollob JA. IRAK4 degrader in hidradenitis suppurativa and atopic dermatitis: a phase 1 trial. Nat Med. 2023 Dec;29(12):3127-3136. doi: 10.1038/s41591-023-02635-7. Epub 2023 Nov 13.
PMID: 37957373

MeSH Terms

Conditions

Dermatitis, AtopicHidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, BacterialBacterial Infections

Study Officials

Ashwin Gollerkeri, MD
Kymera Therapeutics, Inc.
STUDY DIRECTOR

Enrollment

154 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: randomized double blind (for Parts A and B only)
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 26, 2021

Study Start

You may not qualify if:

Evidence or history of a clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
Healthy volunteers who have a clinically relevant history or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
Healthy volunteers who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
Female Healthy volunteers who are pregnant, trying to become pregnant or lactating or breastfeeding.
Healthy volunteers who have participated in any investigational drug or device clinical study within 3 months prior to first dosing on this study.
Healthy volunteers who have previously participated in a study with an investigational product or device involving the dosing of a biological targeted at any immune pathway within 1 year prior to Screening.
Male or female patients aged 18 years to 55 years (inclusive) at the time of Screening, and in generally good health, except for AD or HS, and has a BMI of 17.5 to 35.0 kg/m2; and a total body weight \>50 kg (110 lb).
Diagnosis of AD or HS for at least 6 months.
Patients with AD: having at least 10% treatable percentage body surface area at Screening or on Admission (excluding the scalp and designated venous access areas).
Willingness and ability to comply with all contraception requirements as applicable based on reproductive status.
Has adequate venous access with venous access sites having AD-unaffected, non-infected skin to permit repeated PK sampling.
Female patients must have a negative result for the serum pregnancy test at the Screening Visit and on admission.
Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Patients with HS: A total Abscess and Inflammatory Nodule count of ≥4 at baseline
+10 more criteria

A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Other Outcomes (4)

Study Arms (5)

Single ascending dose cohorts in healthy subjects

Multiple ascending dose cohorts in healthy subjects

Food Effect Cohort in healthy subjects

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Multiple dose cohort in HS and AD patients

Multiple dose cohorts in healthy subjects

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Other Outcomes (4)

Study Arms (5)

Single ascending dose cohorts in healthy subjects

Multiple ascending dose cohorts in healthy subjects

Food Effect Cohort in healthy subjects

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Multiple dose cohort in HS and AD patients

Multiple dose cohorts in healthy subjects

You may not qualify if:

Source record

Locations