200 Participants Needed

KT-621 for Eczema

(BROADEN2 Trial)

Recruiting at 1 trial location
KM
Overseen ByKymera Medical Director
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KT-621 for individuals with moderate-to-severe atopic dermatitis, a type of eczema that causes red and itchy skin. The study aims to evaluate KT-621's effectiveness in reducing symptoms and its safety. Participants will receive either varying doses of KT-621 or a placebo (a substance with no active medicine) for comparison. Those who have had chronic eczema for at least three years and continue to struggle with symptoms despite using topical medications might be suitable for this trial. As a Phase 2 trial, this research measures KT-621's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eczema treatment.

Do I have to stop taking my current medications for the KT-621 eczema trial?

The trial information does not clearly state if you need to stop taking your current medications. However, it mentions that you must not be taking any prespecified prohibited therapies within a specific timeframe, as evaluated by the Investigator. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that KT-621 is likely to be safe for humans?

Research has shown that KT-621 was safe in earlier studies. One study found that participants tolerated KT-621 well, with safety similar to a placebo. Another trial reported no major safety concerns with KT-621. These findings suggest KT-621 might be safe for humans. However, all treatments can have side effects, and results can vary between individuals. Discuss any concerns with a doctor.12345

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

Unlike the standard treatments for eczema, which often include topical steroids and calcineurin inhibitors, KT-621 is unique because it targets a novel pathway in the inflammatory process. This targeted action could potentially reduce inflammation more effectively and with fewer side effects. Researchers are excited about KT-621 because it offers a fresh approach with the possibility of better long-term control of eczema symptoms, providing hope for patients who may not respond well to existing therapies.

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

Research has shown that KT-621 offers promising results for treating moderate-to-severe atopic dermatitis, a common form of eczema. Studies have found that KT-621 effectively breaks down STAT6, a protein causing inflammation, in both blood and skin. Reducing inflammation is crucial for relieving eczema symptoms. Previous trials found that KT-621 is well tolerated by patients and has a safety profile similar to existing treatments like dupilumab. Early results demonstrated that the drug is quickly absorbed and positively affects biomarkers, indicating how the drug works in the body. These findings suggest that KT-621 could effectively reduce the severity of eczema. Participants in this trial will receive different doses of KT-621 or a placebo to further evaluate its effectiveness and safety.12346

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe atopic dermatitis, commonly known as eczema. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.

Inclusion Criteria

Must have an EASI score ≥ 16 at the Screening and Baseline visits
Must have a vIGA-AD score ≥ 3 at the Screening and Baseline visits
Must agree to contraceptive requirements in compliance with the clinical study and local requirements
See 7 more

Exclusion Criteria

Must not have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks before the baseline visit
Must not have a history of alcohol or substance abuse within the previous 2 years
Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KT-621 or placebo in a 16-week double-blind, placebo-controlled study

16 weeks

Open-label extension

Participants may continue to receive KT-621 in a 52-week open-label period

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KT-621
Trial Overview The study tests KT-621's effectiveness in reducing the severity of eczema compared to a placebo over 16 weeks. It's double-blind, meaning neither participants nor researchers know who gets the real drug or placebo during this phase.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: KT-621 Dose 3Experimental Treatment1 Intervention
Group II: Group 2: KT-621 Dose 2Experimental Treatment1 Intervention
Group III: Group 1: KT-621 Dose 1Experimental Treatment1 Intervention
Group IV: Group 4: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
850+

Citations

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