Phase 3 Eczema Trial, Recruiting (NCT07265479)

Phase 3 Eczema Trial, Recruiting NCT07265479 Sponsor: Organon and Co Condition: Eczema

Printed from Voxsanity (voxsanity.com.au) — NCT07265479 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Eczema

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Your baby or toddler was born at full term (at or after 37 weeks of pregnancy) and is between 3 months and under 24 months old at the screening visit
Your child has been diagnosed with atopic dermatitis (eczema) that covers more than 5% of their body, with a confirmed severity score rated by a doctor
You, as the parent or main caregiver, are willing and able to sign a consent form before any study activities begin
You, as the parent or main caregiver, are able and willing to follow all the requirements of the study

Who may not be able to join:

Your child has a significant neurological condition or a history of seizures
Your child has a known, clinically significant heart rhythm problem or heart condition
There is a history of sudden infant death syndrome (SIDS) in a sibling of your child
Your child has a significant chromosomal abnormality
Your child has a serious ongoing or past illness, or physical or mental health condition that could interfere with taking part in the study
Your child has a condition that could cause itching or disrupted sleep (separate from eczema)
Your child's immune system is weakened or not working properly
Your child currently has an ongoing infection (short-term or long-term) that requires treatment
Your child is currently using any medications or undergoing procedures that are not allowed in this study (confirm with trial site)
If your child is breastfed, the breastfeeding mother is taking any medications that are not allowed in this study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 27 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Lead Late-Stage Clinical Development, Organon and Co

Phone: 551-430-6000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07265479

Sponsor: Organon and Co

Phase: Phase 3

Status: Recruiting

Condition: Eczema

Trial contact: 551-430-6000

More information: https://clinicaltrials.gov/study/NCT07265479

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Your baby or toddler was born at full term (at or after 37 weeks of pregnancy) and is between 3 months and under 24 months old at the screening visit
Your child has been diagnosed with atopic dermatitis (eczema) that covers more than 5% of their body, with a confirmed severity score rated by a doctor
You, as the parent or main caregiver, are willing and able to sign a consent form before any study activities begin
You, as the parent or main caregiver, are able and willing to follow all the requirements of the study

Who may not be able to join:

Your child has a significant neurological condition or a history of seizures
Your child has a known, clinically significant heart rhythm problem or heart condition
There is a history of sudden infant death syndrome (SIDS) in a sibling of your child
Your child has a significant chromosomal abnormality
Your child has a serious ongoing or past illness, or physical or mental health condition that could interfere with taking part in the study
Your child has a condition that could cause itching or disrupted sleep (separate from eczema)
Your child's immune system is weakened or not working properly
Your child currently has an ongoing infection (short-term or long-term) that requires treatment
Your child is currently using any medications or undergoing procedures that are not allowed in this study (confirm with trial site)
If your child is breastfed, the breastfeeding mother is taking any medications that are not allowed in this study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Organon and Co

Registry

ClinicalTrials.gov

Start date

29 December 2025

Est. completion

1 January 2028

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Percentage of participants who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement from Baseline to Week 8; Percentage of participants who enter with or achieve have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) and a minimum 2-grade Improvement at least once during the Open-Label Period

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov