A Study to Evaluate the Long-term Safety and Effectiveness of APG777 in Subjects with Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Apogee Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

6 Oct 2025 → ongoing

Decision date (initial)

2026-02-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Others, Safety, Efficacy

To evaluate the long-term safety and tolerability of APG777 in patients with moderate-to-severe AD.

Secondary objectives 4

1. To evaluate the long-term efficacy of APG777 in patients with moderate-to-severe AD during the Extended Treatment Period.
2. To evaluate the long-term effect of APG777 on the maintenance of response in the Extended Treatment Period.
3. To evaluate the long-term safety and tolerability of APG777 on other safety measures in patients with moderate-to-severe AD.
4. To characterize the long-term PK of APG777 in patients with moderate-to-severe AD.

Conditions and MedDRA coding

Atopic Dermatitis

Regulatory references

Plan to share IPD

No

IPD plan description

Not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator’s opinion, compliant with the study protocol
2. Participants who, in the Investigator’s opinion, would benefit from long-term treatment with APG777
3. Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study

Exclusion criteria 4

1. Participants who have developed an AE while participating in the Parent Study which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
2. Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
3. Use of any of the prohibited medications in the Parent Study through Screening Visit (Visit 1) of the LTE study
4. Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 3 years]

Secondary endpoints 10

1. Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline [Time Frame: Through Extended Treatment Period, an average of 2 years]
2. Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline. [Time Frame: Through Extended Treatment Period, an average of 2 years]
3. Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline [Time Frame: Through Extended Treatment Period, an average of 2 years]
4. Percentage of Participants who use Rescue Therapy [Time Frame: Through Extended Treatment Period, an average of 2 years]
5. Percentage of Participants Who Continue to Exhibit EASI 75 Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]
6. Percentage of Participants Who Continue to Exhibit vIGA-AD Response Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]
7. Percentage of Participants Who Continue to Exhibit I-NRS Response Of the participants who achieve a ≥ 4-point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]
8. Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs [Time Frame: Up to 3 years]
9. Serum Concentrations of APG777 Over Time [Time Frame: Up to 3 years]
10. Predose Serum Concentrations of APG777 [Time Frame: Up to 3 years]

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Apogee Therapeutics Inc.

Sponsor organisation

Apogee Therapeutics Inc.

Address

221 Crescent Street Building 17 Suite 102 B

City

Waltham

Postcode

02453-3475

Country

United States

Scientific contact point

Organisation

Apogee Therapeutics Inc.

Contact name

Study Director

Public contact point

Organisation

Apogee Therapeutics Inc.

Contact name

Study Director

Third parties 12

Locations

6 EU/EEA countries · 40 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 75 files

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

Application history

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