ClinicalTrials.gg
RecruitingNCT07003425Updated Nov 3, 2026

A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

A Phase 2 interventional study of APG777 and APG777 in Atopic Dermatitis, sponsored by Apogee Therapeutics, Inc.. Recruiting at 80 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Apogee Therapeutics, Inc. (part of AbbVie) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Updated Nov 3, 2026First site in FranceStudy contact changed+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
350
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).

The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.

This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.

02

Conditions studied

  • Atopic Dermatitis

Browse trials for

Keywords

  • Atopic Dermatitis
  • APG777
  • Safety
  • Efficacy
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 350 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Apogee Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

First submitted before Apogee Therapeutics, Inc. became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol
  • Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777
  • 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

Exclusion Criteria:

  • 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
  • Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
  • Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study
  • Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments

Note: Additional protocol defined Inclusion/Exclusion criteria may apply

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    APG777 - Long Term Extension Treatment - 12 Weeks

    Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).

    Drug: APG777

  • Experimental
    APG777 - Long Term Extension Treatment - 24 Weeks

    Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).

    Drug: APG777

  • Experimental
    APG777 - Open Label Escape Arm

    Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.

    Drug: APG777

Interventions

  • DrugAPG777

    APG777 subcutaneous injection

  • DrugAPG777

    APG777 subcutaneous injection every 12 weeks

  • DrugAPG777

    APG777 subcutaneous injection every 24 weeks

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events

    Time frame: Up to 3 years

Secondary outcomes

  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 up to 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 up to 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 up to 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

07

Study locations

80 of 80 sites recruiting
  • Investigational Site
    Fountain Valley, California 92708, United States
    Recruiting
  • Investigational Site
    Los Angeles, California 90024, United States
    Recruiting
  • Investigational Site
    Coral Gables, Florida 33134, United States
    Recruiting
  • Investigational Site
    Jacksonville, Florida 32256, United States
    Recruiting
  • Investigational Site
    Margate, Florida 33063, United States
    Recruiting
  • Investigational Site
    Douglasville, Georgia 30135, United States
    Recruiting
  • Investigational Site
    Skokie, Illinois 60077, United States
    Recruiting
  • Investigational Site
    Bowling Green, Kentucky 42101, United States
    Recruiting
  • Investigational Site
    Rockville, Maryland 20850, United States
    Recruiting
  • Investigational Site
    Detroit, Michigan 48202, United States
    Recruiting
  • Investigational Site
    Troy, Michigan 48084, United States
    Recruiting
  • Investigational Site
    New York, New York 10023, United States
    Recruiting
  • Investigational Site
    Wilmington, North Carolina 28403, United States
    Recruiting
  • Investigational Site
    Boardman, Ohio 44512, United States
    Recruiting
  • Investigational Site
    Mason, Ohio 45040, United States
    Recruiting
  • Investigational Site
    Portland, Oregon 97223, United States
    Recruiting
  • Investigational Site
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
  • Investigational Site
    Charleston, South Carolina 29425, United States
    Recruiting
  • Investigational Site
    Nashville, Tennessee 37215, United States
    Recruiting
  • Investigational Site
    Dallas, Texas 75230, United States
    Recruiting
  • Investigational Site
    Frisco, Texas 75235, United States
    Recruiting
  • Investigational Site
    San Antonio, Texas 78213, United States
    Recruiting
  • Investigational Site
    Mill Creek, Washington 98012, United States
    Recruiting
  • Investigational Site
    Calgary, Alberta T2J 7E1, Canada
    Recruiting
  • Investigational Site
    Calgary, Alberta T3E 0B2, Canada
    Recruiting
  • Investigational Site
    Edmonton, Alberta T5J 3S9, Canada
    Recruiting
  • Investigational Site
    Vancouver, British Columbia V5Z 4E8, Canada
    Recruiting
  • Investigational Site
    Fredericton, Brunswick E3B 1G9, Canada
    Recruiting
  • Investigational Site
    Ajax, Ontario L1S 7K8, Canada
    Recruiting
  • Investigational Site
    Markham, Ontario L3P 1X3, Canada
    Recruiting
  • Investigational Site
    Mississauga, Ontario L4Y 4C5, Canada
    Recruiting
  • Investigational Site
    Ottawa, Ontario K1K 4L2, Canada
    Recruiting
  • Investigational Site
    Peterborough, Ontario K9J 5K2, Canada
    Recruiting
  • Investigational Site
    Toronto, Ontario M3B 0A7, Canada
    Recruiting
  • Investigational Site
    Toronto, Ontario M4E 2Y9, Canada
    Recruiting
  • Investigational Site
    Toronto, Ontario M4W 2N4, Canada
    Recruiting
  • Investigational Site
    Montreal, Quebec H2X 2V1, Canada
    Recruiting
  • Investigational Site
    Québec, Quebec G1V 4X7, Canada
    Recruiting
  • Investigational Site
    Prague, Prague 128 00, Czechia
    Recruiting
  • Investigational Site
    Prague, Prague Motol 150 06, Czechia
    Recruiting
  • Investigational Site
    Prague, Vinohrady 100 34, Czechia
    Recruiting
  • Investigational Site
    Prague, 100 00, Czechia
    Recruiting
  • Investigational Site
    Prague, 16000, Czechia
    Recruiting
  • Investigational Site
    Martigues, 13500, France
    Recruiting
  • Investigational Site
    Freiburg im Breisgau, Baden-Wurttemberg 79104, Germany
    Recruiting
  • Investigational Site
    Heidelberg, Baden-Wurttemberg 69120, Germany
    Recruiting
  • Investigational Site
    Tübingen, Baden-Wurttemberg 72076, Germany
    Recruiting
  • Investigational Site
    Augsburg, Bavaria 86179, Germany
    Recruiting
  • Investigational Site
    München, Bavaria 80337, Germany
    Recruiting
  • Investigational Site
    Blankenfelde-Mahlow, Brandenburg 15831, Germany
    Recruiting
  • Investigational Site
    Darmstadt, Hesse 64283, Germany
    Recruiting
  • Investigational Site
    Frankfurt am Main, Hesse 60590, Germany
    Recruiting
  • Investigational Site
    Bad Bentheim, Lower Saxony 48455, Germany
    Recruiting
  • Investigational Site
    Münster, North Rhine Westfalia 48149, Germany
    Recruiting
  • Investigational Site
    Dresden, Saxony 1307, Germany
    Recruiting
  • Investigational Site
    Kiel, Schleswig-Holstein 24105, Germany
    Recruiting
  • Investigational Site
    Berlin, 10117, Germany
    Recruiting
  • Investigational Site
    Hamburg, 20354, Germany
    Recruiting
  • Investigational Site
    Szeged, Csongrad-Csanad 6720, Hungary
    Recruiting
  • Investigational Site
    Debrecen, Hajdú-Bihar 4032, Hungary
    Recruiting
  • Investigational Site
    Budapest, 1085, Hungary
    Recruiting
  • Investigational Site
    Wroclaw, Lower Silesian Voivodeship 50-450, Poland
    Recruiting
  • Investigational Site
    Wroclaw, Lower Silesian Voivodeship 51-503, Poland
    Recruiting
  • Investigational Site
    Lublin, Lublin Voivodeship 20-573, Poland
    Recruiting
  • Investigational Site
    Warsaw, Masovian Voivodeship 01-595, Poland
    Recruiting
  • Investigational Site
    Warsaw, Masovian Voivodeship 02-482, Poland
    Recruiting
  • Investigational Site
    Gdansk, Pomeranian Voivodeship 80-546, Poland
    Recruiting
  • Investigational Site
    Katowice, Silesian Voivodeship 40-600, Poland
    Recruiting
  • Investigational Site
    Sosnowiec, Silesian Voivodeship 41-218, Poland
    Recruiting
  • Investigational Site
    Szczecin, West Pomeranian Voivodeship 71-500, Poland
    Recruiting
  • Investigational Site
    Krakow, Woj. Małopolskie 30-727, Poland
    Recruiting
  • Investigational Site
    Lodz, 90-237, Poland
    Recruiting
  • Investigational Site
    Santiago de Compostela, A Coruña 15706, Spain
    Recruiting
  • Investigational Site
    Badalona, Barcelona 8916, Spain
    Recruiting
  • Investigational Site
    Las Palmas de Gran Canaria, Canary Islands 35010, Spain
    Recruiting
  • Investigational Site
    Alicante, 3010, Spain
    Recruiting
  • Investigational Site
    Madrid, 28006, Spain
    Recruiting
  • Investigational Site
    Salford, Greater Manchester M6 8HD, United Kingdom
    Recruiting
  • Investigational Site
    Dudley, West Midlands DY2 1HQ, United Kingdom
    Recruiting
  • Investigational Site
    London, SE1 9RT, United Kingdom
    Recruiting
08

Updates

3 registry updates since Sep 25, 2026
Sites
7 sites added — first site in France
Show 7 added (2 Hungary, 2 Spain, 1 France, 1 United Kingdom, 1 Germany)
  • Investigational Site · Martigues, France
  • Investigational Site · Szeged, Hungary
  • Investigational Site · Budapest, Hungary
  • Investigational Site · Badalona, Spain
  • Investigational Site · Alicante, Spain
  • Investigational Site · Dudley, United Kingdom
  • Investigational Site · Freiburg im Breisgau, Germany
across 3 updates, Oct 13, 2026 – Nov 3, 2026
Contact
Study contact changed: C•••@apogeetherapeutics.com · •••2408→a•••@abbvie.com · •••3742. See the current contact
Oct 13, 2026
Show all 3 updates
  1. Nov 3, 2026
    1 site added
    Show site
    • Investigational Site · Freiburg im Breisgau, Germany
    + 1 other change: verification date
  2. Oct 22, 2026
    1 site added
    Show site
    • Investigational Site · Dudley, United Kingdom
  3. Oct 13, 2026
    5 sites added — first site in France
    Show 5 added (2 Hungary, 2 Spain, 1 France)
    • Investigational Site · Martigues, France
    • Investigational Site · Szeged, Hungary
    • Investigational Site · Budapest, Hungary
    • Investigational Site · Badalona, Spain
    • Investigational Site · Alicante, Spain
    Contact Study contact changed: C•••@apogeetherapeutics.com · •••2408→a•••@abbvie.com · •••3742. See the current contact
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07003425
Responsible party
Sponsor
First posted
Jun 4, 2025
Start date
May 14, 2025
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Zumilokibart

Start the discussion