AzTrials
AzTrials

Atopic DermatitisPhase 2NCT06395948

A Study Evaluating APG777 in Atopic Dermatitis

A Phase 2 study testing APG777 in people with Atopic Dermatitis, run by Apogee Therapeutics, Inc. at 94 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
APG777
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
470 participants
Where
94 sitesin 9 countries
Study dates
29 Apr 2024to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit
  • Moderate-to-severe AD at Screening and Baseline visits
  • History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
  • 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.
  • Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit

Who cannot join

  • Participation in a prior study with APG777.
  • Prior treatment with protocol-specified monoclonal antibodies (mAbs)
  • Has used any AD-related topical medications within 7 days prior to Baseline visit.
  • 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
  • Note: Other protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

94 sites in 9 countries.

94 sites in 9 countries

United States29 sites

  • Investigational Site

    Boardman, Ohio, 44512

  • Investigational Site

    Bowling Green, Kentucky, 42104

  • Investigational Site

    Charleston, South Carolina, 29425

  • Investigational Site

    Chicago, Illinois, 60657

  • Investigational Site

    Coral Gables, Florida, 33134

  • Investigational Site

    Dallas, Texas, 75230

  • Investigational Site

    Dallas, Texas, 75235

  • Investigational Site

    Detroit, Michigan, 48202

  • Investigational Site

    Douglasville, Georgia, 30135

  • Investigational Site

    Fountain Valley, California, 92708

  • Investigational Site

    Jacksonville, Florida, 32256

  • Investigational Site

    Los Angeles, California, 90024

  • Investigational Site

    Margate, Florida, 33063

  • Investigational Site

    Mason, Ohio, 45040

  • Investigational Site

    Mill Creek, Washington, 98012

  • Investigational Site

    Nashville, Tennessee, 37215

  • Investigational Site

    New Haven, Connecticut, 06519

  • Investigational Site

    New York, New York, 10023

  • Investigational Site

    Norfolk, Virginia, 23502

  • Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Investigational Site

    Portland, Oregon, 97201

  • Investigational Site

    Portsmouth, New Hampshire, 13801

  • Investigational Site

    Rockville, Maryland, 20850

  • Investigational Site

    San Antonio, Texas, 78213

  • Investigational Site

    San Diego, California, 92123

  • Investigational Site

    Skokie, Illinois, 60077

  • Investigational Site

    Troy, Michigan, 48084

  • Investigational Site

    West Lafayette, Indiana, 47906

  • Investigational Site

    Wilmington, North Carolina, 28403

Other trials in United States

Canada16 sites

  • Investigational Site

    Ajax, Ontario, L1S 7K8

  • Investigational Site

    Calgary, Alberta, T2J 7E1

  • Investigational Site

    Calgary, Alberta, T3E 0B2

  • Investigational Site

    Edmonton, Alberta, T5J 3S9

  • Investigational Site

    Fredericton, New Brunswick, E3B 1G9

  • Investigational Site

    Markham, Ontario, L3P 1X3

  • Investigational Site

    Mississauga, Ontario, L4Y 4C5

  • Investigational Site

    Montreal, Quebec, H2X 2V1

  • Investigational Site

    Ottawa, Ontario, K1K 4L2

  • Investigational Site

    Peterborough, Ontario, K9J 5K2

  • Investigational Site

    Québec, Quebec, G1V4X7

  • Investigational Site

    Toronto, Ontario, M3B 0A7

  • Investigational Site

    Toronto, Ontario, M4E 2Y9

  • Investigational Site

    Toronto, Ontario, M4W 2N4

  • Investigational Site

    Vancouver, British Columbia, V5Z 4E8

  • Investigational Site

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Germany16 sites

  • Investigational Site

    Augsburg, Bavaria, 86179

  • Investigational Site

    Bad Bentheim, Lower Saxony, 48455

  • Investigational Site

    Berlin, 10117

  • Investigational Site

    Blankenfelde-Mahlow, Brandenburg, 15831

  • Investigational Site

    Darmstadt, Hesse, 64283

  • Investigational Site

    Dresden, Saxony, 01307

  • Investigational Site

    Frankfurt am Main, Hesse, 60590

  • Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • Investigational Site

    Hamburg, 20246

  • Investigational Site

    Hamburg, 20354

  • Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • Investigational Site

    München, Bavaria, 81377

  • Investigational Site

    Münster, North Rhine Westfalia, 48149

  • Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Poland11 sites

  • Investigational Site

    Gdansk, Pomeranian Voivodeship, 80-546

  • Investigational Site

    Katowice, Silesian Voivodeship, 40-600

  • Investigational Site

    Krakow, Woj. Małopolskie, 30-727

  • Investigational Site

    Lodz, Łódź Voivodeship, 90-338

  • Investigational Site

    Lublin, Lublin Voivodeship, 20-573

  • Investigational Site

    Sosnowiec, Silesian Voivodeship, 41-218

  • Investigational Site

    Szczecin, West Pomeranian Voivodeship, 71-500

  • Investigational Site

    Warsaw, Masovian Voivodeship, 01-595

  • Investigational Site

    Warsaw, Masovian Voivodeship, 02-482

  • Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 50-450

  • Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 51-503

Other trials in Poland

Spain8 sites

  • Investigational Site

    Alicante, 03010

  • Investigational Site

    Badalona, Barcelona, 08916

  • Investigational Site

    Barcelona, 08041

  • Investigational Site

    Las Palmas de Gran Canaria, Canary Islands, 35010

  • Investigational Site

    Madrid, 28006

  • Investigational Site

    Madrid, 28040

  • Investigational Site

    Santiago de Compostela, A Coruña, 15706

  • Investigational Site

    Zaragoza, 50009

Other trials in Spain

Czechia5 sites

  • Investigational Site

    Prague, 10000

  • Investigational Site

    Prague, 10034

  • Investigational Site

    Prague, 11000

  • Investigational Site

    Prague, 15006

  • Investigational Site

    Prague, 16000

Other trials in Czechia

France3 sites

  • Investigational Site

    Martigues, 13500

  • Investigational Site

    Nantes, 44093

  • Investigational Site

    Rouen, Normandy, 76031

Other trials in France

Hungary3 sites

  • Investigational Site

    Budapest, 1085

  • Investigational Site

    Debrecen, Hajdú-Bihar, 4032

  • Investigational Site

    Szeged, 6720

Other trials in Hungary

United Kingdom3 sites

  • Investigational Site

    Dudley, West Midlands, DY1 2HQ

  • Investigational Site

    London, SE1 9RT

  • Investigational Site

    Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

About this study

Official title: A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

Being tested
APG777, Placebo
Keywords
Atopic Dermatitis, APG777, Safety, Efficacy
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APG777Drug

    APG777 subcutaneous injection

  • PlaceboDrug

    Matching placebo subcutaneous injection

Study groups in NCT06395948
Study groupRoleWhat they receive
Part A: Induction Period: APG777ExperimentalParticipants will receive APG777 per protocol defined dosing regimen
Receives: Drug: APG777
Part A: Induction Period: PlaceboPlacebo comparatorParticipants will receive matching Placebo injections per protocol defined dosing regimen
Receives: Drug: Placebo
Part A: Maintenance Period: APG777ExperimentalParticipants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
Receives: Drug: APG777
Part B: Induction Period: APG777ExperimentalParticipants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
Receives: Drug: APG777
Part B: Induction Period: PlaceboPlacebo comparatorParticipants will receive matching placebo injections per protocol defined dosing regimen
Receives: Drug: Placebo
Part B: Maintenance Period: APG777ExperimentalParticipants will receive APG777 per protocol defined dosing regimen
Receives: Drug: APG777

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)

    Measured: Baseline and at Week 16

  2. Part B: Proportion of participants who achieve EASI 75 at Week 16

    Measured: At Week 16

Secondary outcomes (14)

  1. Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 106 Weeks

  2. Part A and B: Change from Baseline in EASI

    Measured: Baseline, through Week 16 and at Week 52

  3. Part A and B: Percent Change from Baseline in EASI

    Measured: Baseline through Week 16 and at Week 52

  4. Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score

    Measured: Baseline through Week 16 and at Week 52

  5. Part A and B: Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >= 2-Point Reduction

    Measured: Baseline through Week 16 and at Week 52

  6. Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement

    Measured: Baseline through Week 16 and at Week 52

  7. Part A and B: Proportion of Participants Achieving a >= 4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS)

    Measured: Baseline through Week 16 and at Week 52

  8. Part A and B: Percent Change from Baseline in the Weekly Mean of the Daily I-NRS

    Measured: Baseline through Week 16 and at Week 52

  9. Part A and B: Serum Concentrations of APG777 Over Time

    Measured: Up to 106 Weeks

  10. Part A and B: Predose Serum Concentrations of APG777 (Ctrough)

    Measured: Up to 106 Weeks

  11. Part A and B: Maximum concentration (Cmax) of APG777

    Measured: Up to 106 Weeks

  12. Part A and B: Time to reach Cmax (tmax)

    Measured: Up to 106 Weeks

  13. Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period

    Measured: Baseline to 16 Weeks

  14. Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period

    Measured: 16 Weeks to 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start29 Apr 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395948
Sponsor's protocol ID
APG777-201
Status last verified
Oct 2026
First submitted
29 Apr 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lim XQ, Winter E, Nograles K, Xu J, Zhang ZQ, Thankamony S, Dillinger L, Dambkowski CL. A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers. Clin Transl Sci. 2025 Dec;18(12):e70456. doi: 10.1111/cts.70456.

    PubMed 41422501

  • Rubio D, Zhu E, Thurston A, Funk KA, York KA, Dambkowski CL, Badger D. Preclinical Safety of APG777, A Novel Extended Half-Life Anti-Interleukin-13 Monoclonal Antibody, in Cynomolgus Monkeys. Int J Toxicol. 2025 Nov-Dec;44(6):443-450. doi: 10.1177/10915818251355584. Epub 2025 Jul 30.

    PubMed 40739793

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APG777 in people with Atopic Dermatitis, run by Apogee Therapeutics, Inc. at 94 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Canada, Germany, Poland, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI) (time frame: Baseline and at Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06395948, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in