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A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants with Moderate to Severe Atopic Dermatitis

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522370-36-00
Acronym
KT621-AD-201
Enrollment
108
Registered
2026-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Atopic Dermatitis

Brief summary

• Percentage change from baseline to Week 16 in the EASI score

Detailed description

• Proportion of participants with EASI-50, EASI-75, and EASI-90 at Week 16, • Proportion of participants who achieve a vIGA-AD score of 0 to 1 (on a 5-point scale) and a reduction from baseline of at least 2 points at Week 16, • Proportion of participants with at least a 4-point improvement in the Peak Pruritus NRS at Week 16, •Incidence of TEAEs through Week 16, • Incidence of treatment-emergent SAEs through Week 16, • Incidence of TEAEs from Week 16 through Week 68, • Incidence of treatment-emergent SAEs from Week 16 through Week 68, • Plasma PK parameter estimates of KT-621 derived from plasma concentration time data to Week 16 and Week 68

Interventions

DRUGThe placebo is used in the Double-blind
DRUGPlacebo-controlled (DBPC) Treatment Period. Participants are randomly assigned to receive either KT-621 or a matching placebo. The placebo is designed to match the study drug in appearance and administration method to maintain blinding.
DRUGKT-621

Sponsors

Kymera Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Percentage change from baseline to Week 16 in the EASI score—

Secondary

MeasureTime frame
• Proportion of participants with EASI-50, EASI-75, and EASI-90 at Week 16, • Proportion of participants who achieve a vIGA-AD score of 0 to 1 (on a 5-point scale) and a reduction from baseline of at least 2 points at Week 16, • Proportion of participants with at least a 4-point improvement in the Peak Pruritus NRS at Week 16, •Incidence of TEAEs through Week 16, • Incidence of treatment-emergent SAEs through Week 16, • Incidence of TEAEs from Week 16 through Week 68, • Incidence of treatment-emergent SAEs from Week 16 through Week 68, • Plasma PK parameter estimates of KT-621 derived from plasma concentration time data to Week 16 and Week 68—

Countries

Czechia, Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026