Phase 3 Eczema Trial, Completed NCT01949311 Sponsor: Regeneron Pharmaceuticals Condition: Eczema
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT01949311) enrolled 2,677 people, all of whom received the medicine dupilumab. The trial was a single-group study — meaning there was no separate comparison or placebo group — and it was primarily focused on tracking adverse events (that is, any unwanted medical occurrences that happened during the study period). Of the 2,677 people who started, 1,297 completed the study, while 1,380 did not complete it; the reasons for not completing were not detailed in the data provided here. The reported data shows that across all participants, 14,717 treatment-emergent adverse events (meaning unwanted medical occurrences that happened after starting the treatment) were recorded in total. The trial also specifically tracked certain pre-defined "adverse events of special interest" — a set of particular medical events including serious allergic reactions, certain eye conditions, and some types of infections. According to the results reported on ClinicalTrials.gov, 161 of these special-interest events were recorded across the group, at a rate of approximately 2.76 such events per person per year. Nine of these special-interest events were classified as serious. An optional sub-study looking at these same special-interest events after participants switched to a new version of the dupilumab product reported zero such events, though the size of that sub-group was not detailed in the submitted data. The reported data also includes a skin severity score called the IGA (Investigator's Global Assessment), which rates skin condition on a scale from 0 (clear) to 4 (severe). At the start of the study, 12% of participants had a score of 0 or 1 (clear or almost clear skin). Across later check-in points, that percentage was reported to rise, reaching as high as 81.2% at one recorded visit, though the timing of each individual measurement was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Eczema Trial, Completed

NCT01949311
Completed Phase 3 🇦🇺 Australian site

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:

  • You previously took part in a clinical trial of dupilumab for eczema (atopic dermatitis) and completed the required visits and assessments in that trial
  • You previously received dupilumab in a specific type of trial that has finished, even if you didn't participate for the full duration, as long as you followed the instructions given during that study
  • You went through the screening process for one of two specific dupilumab trials (Liberty AD SOLO 1 or SOLO 2) but were unable to be assigned to a treatment group because the trial closed enrollment before you could join
  • You are willing and able to attend all clinic visits and follow all study procedures
  • You are able to understand and fill out study questionnaires
  • You are able to sign a consent form agreeing to take part

For the optional part of the study, you must also:

  • Be willing to sign a separate consent form for that part
  • Still be in the active treatment phase of the main study
  • Have shown that you have been taking dupilumab as instructed (confirm with trial site)

Who may not be able to join:

  • You had a serious side effect during a previous dupilumab trial that was believed to be caused by dupilumab, and the doctor feels that continuing the treatment could put you at unreasonable risk
  • You had a side effect in a previous dupilumab trial that was believed to be caused by dupilumab and led to you stopping the treatment, and the doctor feels continuing could be unsafe for you
  • You had a condition during a previous dupilumab trial that required you to permanently stop the study drug, or you were withdrawn from the study — for example, due to not following the study rules or being unable to complete the required assessments
  • You have taken another experimental drug (other than dupilumab) within the past 8 weeks, or within 5 times that drug's clearance time from the body (whichever is longer), before the start of this study
  • You are currently pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

For the optional part of the study, you may not be able to join if:

  • You have already completed the final treatment visit for the main related 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 Trial Management, Regeneron Pharmaceuticals

Australian sites

Regeneron Study Site, Phillip, Australian Capital Territory
Regeneron Study Site, Kogarah, New South Wales
Regeneron Study Site, Benowa, Queensland
Regeneron Study Site, Woolloongabba, Queensland
Regeneron Study Site, Hectorville, South Australia
Regeneron Study Site, Carlton, Victoria
Regeneron Study Site, East Melbourne, Victoria
Regeneron Study Site, Fremantle, Western Australia

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.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
10 October 2013
Est. completion
27 June 2022

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇯🇵 Japan 🇱🇹 Lithuania 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇸🇬 Singapore 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Treatment Emergent Adverse Events (TEAEs); OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product

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