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DO YOU HAVE ADOLESCENT PATIENTS
WITH ATOPIC DERMATITIS?

Learn about the AD-12345 study.

CONSIDER THE AD-12345 STUDY FOR YOUR ADOLESCENT PATIENTS WITH ATOPIC DERMATITIS (AD).

This study is:

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Open label

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Phase III

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Exploring long-term safety and tolerability of adermtuximab

GIVE YOUR PATIENTS THE STUDY BROCHURE

Download brochure
brochure

Copy the patient website link into your patient notes.

STUDY SITE LOCATIONS

For nearby site locations and contact information, click on the map below.

Location

Click to copy nearby study site locations into your patient notes.

INCLUSION AND EXCLUSION CRITERIA

Patients who meet the following criteria may be eligible to participate:

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12 to 17 years old

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AD diagnosis as defined by Hanifin and Rajka criteria

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AD duration of at least 2 years

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Total IGA score of 2 or 3

The AD-12345 Study is Now Enrolling Patients with Mild to Moderate AD.

AD-12345 Study Summary

study drugs

Medical condition:
Mild to moderate atopic
dermatitis

Participant Age

Study drug:
Adermtuximab
1.5% cream

Sponsor

Age of participants:
12-17 years old

Enrollment Period

Sponsor:
DermaticEffect Pharma

Enrollment Period

Accepts healthy volunteers:
No

Enrollment Period

Enrollment Period:
Currently enrolling through
January 2023

FAQ
What is the primary objective of the AD-12345 study?

To evaluate the long-term safety and tolerability of adermtuximab cream in adolescents with AD.

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What is the study drug being evaluated in the AD-12345 study?

Adermtuximab 1.5% cream is FDA approved in the US.

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If my patient qualifies for the AD-12345 study, will they receive the study drug?

All participants will receive adermtuximab 1.5% cream.

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Are patients with severe AD eligible for this study?

No, AD-12345 is for patients with mild to moderate AD.

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How many participants will be in this study?

Approximately 100 participants will be enrolled.

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Learn more about this study on ClinicalTrials.gov:
NCT00000000

Click here to contact a site near you.

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Protocol number: ABCD 123-456
ClinicalTrials.gov NCT00000000
PRIVACY POLICY
Copyright © 2023 DermaticEffect Pharma. All rights reserved.
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ABCD 123-456

Inclusion Criteria

Exclusion Criteria

Participants are eligible for study inclusion if all the following criteria apply:

  1. Adolescents aged ≥ 12 years to < 18 years (at the screening visit).

  2. A diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.

  3. Duration of AD of at least 2 years.

  4. Total IGA score of 2 to 3 at the screening and baseline visits.

  5. Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.

  6. Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable.
    See Section 8.1.5.2 of protocol for further details.

  7. Agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

  8. Willingness to avoid pregnancy or fathering children based on the criteria below.

    • Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last application of adermtuximab cream and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy (see Appendix A of protocol) should be communicated to the participants and their understanding confirmed.

    • Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first application of adermtuximab cream on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last application of adermtuximab cream and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy (see Appendix A of protocol) should be communicated to the participants and their understanding confirmed.

    • A female participant not considered to be of childbearing potential as defined in Appendix A (of protocol) is eligible.

  9. Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian(s) and written assent from the participant when possible.
    Note: Participants who become legal adults during the study will be asked for their signed consent to continue the study, and in the event of lack thereof, will be discontinued from further participation.