Health TrialsbyHealthPanel

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

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorApogee Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • APG777

    Drug

    APG777 subcutaneous injection

  • APG777

    Drug

    APG777 subcutaneous injection every 12 weeks

  • APG777

    Drug

    APG777 subcutaneous injection every 24 weeks

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: APG777 - Long Term Extension Treatment - 12 WeeksExperimental treatment 1 intervention
Group B: APG777 - Long Term Extension Treatment - 24 WeeksExperimental treatment 1 intervention
Group C: APG777 - Open Label Escape ArmExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Apogee Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now