A Study to Evaluate the 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

3 Sep 2024 → ongoing

Decision date (initial)

2024-11-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Apogee Therapeutics, Inc.

External identifiers

EU CT number

2024-511260-84-00

ClinicalTrials.gov

NCT06395948

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

Part A: To evaluate the effectiveness of APG777 compared to placebo in patients with moderate-to-severe AD after 16 weeks of treatment.
Part B: To evaluate three different doses of APG777 compared to placebo in patients with moderate-to-severe AD after 16 weeks of treatment.

Secondary objectives 8

1. Part A: • To evaluate the safety and tolerability of APG777
2. Part A: • To evaluate the effectiveness of APG777 compared to placebo in patients with moderate-to-severe AD after 52 weeks of treatment
3. Part A: • To evaluate the effectiveness of APG777 compared to placebo in reducing itching, skin pain, as well as the effect of eczema in sleep
4. Part A: • Measuring the amount of study drug in the blood at different times
5. Part B: • To evaluate the safety and tolerability of three different doses of APG777
6. Part B: • To evaluate the effectiveness of three different doses of APG777 compared to placebo in patients with moderate-to-severe AD after 52 weeks of treatment
7. Part B: • To evaluate the effectiveness of APG777 compared to placebo in reducing itching, skin pain, as well as the effect of eczema in sleep
8. Part B: • Measuring the amount of study drug in the blood at different times for three different doses of APG777

Conditions and MedDRA coding

Atopic Dermatitis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. • Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit
2. • Moderate-to-severe AD at Screening and Baseline visits
3. • History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
4. • Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for >=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits
5. • Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit

Exclusion criteria 4

1. • Participation in a prior study with APG777
2. • Prior treatment with protocol-specified monoclonal antibodies (mAbs)
3. • Has used any AD-related topical medications within 7 days prior to Baseline visit
4. • Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16

Secondary endpoints 14

1. Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks]
2. Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52]
3. Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52]
4. Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52]
5. Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52]
6. Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52]
7. Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52]
8. Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through Week 16 and at Week 52]
9. Serum Concentrations of APG777 Over Time [Time Frame: Up to 106 Weeks]
10. Predose Serum Concentrations of APG777 (Ctrough) [Time Frame: Up to 106 Weeks]
11. Maximum concentration (Cmax) of APG777 [Time Frame: Up to 106 Weeks]
12. Time to reach Cmax (tmax) [Time Frame: Up to 106 Weeks]
13. Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period [Time Frame: Baseline to 16 Weeks]
14. AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period [Time Frame: 16 Weeks to 52 Weeks]

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 24

Locations

6 EU/EEA countries · 46 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 163 files

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

Application history

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