KT-621 for Eczema

(BroADen Trial)

Not currently recruiting at 11 trial locations

Overseen By Kymera Medical Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Kymera Therapeutics, Inc.

Must not be taking: Interleukin inhibitors, JAK inhibitors

Disqualifiers: Respiratory, Cardiovascular, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 44

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests KT-621, a new oral treatment for individuals with moderate to severe eczema, also known as atopic dermatitis. The goal is to assess the safety of KT-621 and its effects on the body. Researchers seek participants who have had eczema for at least a year, use moisturizers regularly, and have not responded well to topical treatments. Participants will take KT-621 daily for 28 days to help determine its safety and effectiveness. As a Phase 1 trial, this research focuses on understanding how KT-621 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants with a history of lack of response to certain medications are excluded, which might imply some restrictions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that KT-621 was well-tolerated in earlier studies. In one study, KT-621's safety matched that of a placebo, indicating it did not cause more side effects than a fake treatment. Another study found that KT-621 was safe, absorbed quickly, and effectively influenced the body's indicators of treatment success. This is a Phase 1 study, primarily focused on assessing the treatment's safety and tolerability in humans. Although further research is necessary to confirm its safety, early results appear promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard treatments for eczema, which often include topical corticosteroids and calcineurin inhibitors, KT-621 is taken orally. This makes it a unique option, especially for those who struggle with applying creams or have extensive skin involvement. Researchers are particularly excited about KT-621 because it represents a novel approach that might offer more convenient dosing and potentially improved outcomes for eczema patients. By targeting the condition internally, KT-621 could simplify treatment routines and enhance patient adherence.

What evidence suggests that KT-621 might be an effective treatment for eczema?

Research has shown that KT-621, the treatment under study in this trial, could be a promising option for moderate to severe atopic dermatitis (AD). Studies have found that KT-621 breaks down STAT6, a protein responsible for skin inflammation, a major issue in AD. Early trials indicated that KT-621 is safe and significantly reduces inflammation. Initial results suggest that KT-621 works similarly to dupilumab, a current AD treatment, but offers the convenience of a pill form. Overall, these findings suggest KT-621 could be an effective new option for managing atopic dermatitis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 18-55 with moderate to severe atopic dermatitis (AD) for at least a year can join. They must have an EASI score of 16 or more, vIGA of 3+, and AD on at least 10% body area. Participants need a history of poor response or contraindication to topical AD meds and should use moisturizer regularly.

Inclusion Criteria

Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures

Weekly average Peak Pruritus Numeric Rating Scale (NRS) of at least 4 at the baseline visit

I have used a moisturizer twice daily for the last 7 days.

Exclusion Criteria

Participants who have a clinically relevant history of various diseases or disorders

Participants with a history of alcohol or substance abuse within the previous 2 years

Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral doses of KT-621 for 28 days

4 weeks

Visits on Days 1 and 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Safety follow-up visit on Day 43

What Are the Treatments Tested in This Trial?

Interventions

• KT-621

Trial Overview The trial is testing KT-621, an oral medication for adults with moderate to severe AD. It aims to assess the drug's safety, how well it's tolerated, its movement through and effect on the body, and its effectiveness in reducing symptoms.

How Is the Trial Designed?

Group I: KT-621 Experimental Treatment 1 Intervention

Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period.

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

850+

Published Research Related to This Trial

A review of 24 studies on emollients for atopic dermatitis found that while adverse events were reported, none were serious, suggesting that these treatments are generally safe for use.

The most common adverse events were mild skin reactions, with the proportion of participants experiencing treatment-related issues ranging from 2% to 59%, highlighting the need for better reporting and more comprehensive studies on emollient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. Bhanot, A., Huntley, A., Ridd, MJ.[2021]

In two studies involving 631 adults with moderate to severe atopic dermatitis, tacrolimus ointment (0.03% or 0.1%) was found to be effective, significantly outperforming the vehicle in all measured efficacy parameters over 12 weeks.

While some patients experienced mild adverse events like skin burning and pruritus, these were generally brief and resolved quickly; importantly, tacrolimus ointment was deemed safe, with no significant laboratory changes and low systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. Soter, NA., Fleischer, AB., Webster, GF., et al.[2022]

Tacrolimus ointment, while effective for treating various inflammatory skin diseases, including oral lichen planus, has been associated with potential risks, including an increased risk of cancer, as highlighted by a case where a patient developed squamous cell carcinoma after prolonged use.

The study suggests that tacrolimus may influence cancer signaling pathways, such as the MAPK and p53 pathways, indicating that its carcinogenic effects could extend beyond just immune suppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The carcinogenic potential of tacrolimus ointment beyond immune suppression: a hypothesis creating case report. Becker, JC., Houben, R., Vetter, CS., et al.[2020]

Dermacare, a new cosmetic formulation for atopic dermatitis, was found to be safe and well-tolerated in a multicenter study with no reported adverse events, demonstrating its potential for daily use.

After 28 days of treatment, Dermacare significantly reduced skin barrier disruption, as shown by a 70.4% decrease in the Eczema Area and Severity Index and a 36.7% decrease in transepidermal water loss, indicating improved skin condition and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. de Lucas, R., García-Millán, C., Pérez-Davó, A., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217015

NCT07217015 | A Study of KT-621 Administered Orally to ... This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with moderate-to-severe atopic dermatitis (AD) ...

2. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-positive-first-human-results-phase

Release Details “Our primary objective was to demonstrate that KT-621 could achieve robust STAT6 degradation in blood and skin that was well tolerated, and ...

3. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-late-breaking-oral-presentations

Release Details Featured presentations showcase the positive Phase 1 healthy volunteer trial results supporting KT-621's oral, dupilumab-like profile.

4. dermatologytimes.com dermatologytimes.com/view/kt-621-shows-strong-phase-1-results-as-first-in-class-oral-stat6-degrader

KT-621 Shows Strong Phase 1 Results as First-in-Class ... Phase 1 trial showed rapid absorption, significant STAT6 degradation, and biomarker modulation, with a favorable safety profile.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06945458

Study Details | NCT06945458 | Safety, PK, PD, and Clinical ... This is a study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in adult male and ...

6. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-outlines-key-2025-objectives-and-strategy

Kymera Therapeutics Outlines Key 2025 Objectives and ... Currently in Phase 1 testing, KT-621 has demonstrated dupilumab-like activity and very good safety data in preclinical models. Recruiting for ...