A Study of KT-621 Administered Orally to Participants with Moderate to Severe Atopic Dermatitis (BROADEN2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Kymera Therapeutics Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

2 Feb 2026 → ongoing

Decision date (initial)

2026-01-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Kymera Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others

To evaluate the efficacy of multiple KT-621 doses compared with placebo in participants with moderate to severe AD

Secondary objectives 4

1. •To evaluate the safety and tolerability of multiple doses of KT-621 compared with placebo treatment in participants with moderate to severe AD.
2. •To evaluate the long-term efficacy of KT-621 treatment in participants with moderate to severe AD
3. •To evaluate the long-term safety of KT-621 treatment in participants with moderate to severe AD
4. •To characterize the PK of KT-621 in blood in participants with moderate to severe AD

Conditions and MedDRA coding

Moderate to Severe Atopic Dermatitis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Federal Institute For Drugs And Medical Devices, Danish Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. • 12 to 75 years of age, inclusive, at the time of signing the Informed Consent Form (ICF) or Informed Assent Form (IAF)
2. • Chronic AD (as defined by Hanifin and Rajka [Hanifin, 1980]) that has been present for at least 3 years before the Screening visit (for adults) or for at least 1 year before the Screening visit (for adolescents)
3. • EASI score ≥ 16 at the Screening and Baseline visit
4. • vIGA-AD score ≥ 3 (scale of 0 to 4) at the Screening and Baseline visits
5. • At least 10% BSA of AD involvement at the Screening and Baseline visits
6. • Weekly average Peak Pruritus NRS ≥ 4 at the Baseline visit
7. • History within the 6 months prior to the Baseline visit of either an inadequate response to, or contraindication to topical medications for the treatment of AD
8. • Application of a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit

Exclusion criteria 5

1. • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks prior to Baseline.
2. • Presence of other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments
3. • Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures
4. • Prohibited therapy received within a specified time frame prior to the Baseline visit
5. • History of inadequate response to any therapeutic agent targeting IL-4, IL-13, and/or the JAK-STAT pathway (eg, dupilumab, lebrikizumab, upadacitinib, abrocitinib) at approved doses.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 8

1. • Proportion of participants with EASI-50, EASI-75, and EASI-90 at Week 16
2. • 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
3. • Proportion of participants with at least a 4-point improvement in the Peak Pruritus NRS at Week 16
4. •Incidence of TEAEs through Week 16
5. • Incidence of treatment-emergent SAEs through Week 16
6. • Incidence of TEAEs from Week 16 through Week 68
7. • Incidence of treatment-emergent SAEs from Week 16 through Week 68
8. • Plasma PK parameter estimates of KT-621 derived from plasma concentration time data to Week 16 and Week 68

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kymera Therapeutics Inc.

Sponsor organisation

Kymera Therapeutics Inc.

Address

500 North Beacon Street Floor 4

City

Watertown

Postcode

02472-5801

Country

United States

Scientific contact point

Organisation

Kymera Therapeutics Inc.

Contact name

Kymera Medical Director

Public contact point

Organisation

Kymera Therapeutics Inc.

Contact name

Kymera Medical Director

Third parties 10

Locations

3 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 104 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications