Asthma Trial, Recruiting NCT07425639 Sponsor: Celltrion HealthCare France Condition: Asthma
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Asthma Trial, Recruiting

NCT07425639
Recruiting Not Applicable

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 are 18 years old or older and are receiving specialist care for either severe asthma or chronic spontaneous urticaria (a long-term skin condition causing hives).
  • You have been treated with the medication omalizumab (the original/reference version) for at least 6 months for one of the conditions listed above.
  • Your condition has been stable for at least 3 months, meaning your doctor considers it controlled or in remission — for asthma this is based on specific breathing test results and low use of steroid tablets, and for urticaria this is based on a symptom score (confirm with trial site).
  • Your specialist doctor has already decided, as part of your normal care, to switch you to a medication called OMLYCLO® (a biosimilar version of omalizumab made by Celltrion).
  • You are able to start the new treatment within 60 days of joining the study.
  • You have an email address and a mobile phone number.
  • You are able to understand and fill in questionnaires written in French.
  • You agree to take part in the study.
  • You are covered by the French Social Security system.

Who may not be able to join:

  • You are under legal guardianship, trusteeship, or are otherwise not free to make your own decisions.
  • You are pregnant or could become pregnant and are planning to do so during the treatment period.
  • You are already taking part in another clinical trial or study that does not allow you to join additional studies at the same time.
  • You have a medical reason why you cannot take the study medication (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 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +33 1 71 25 27 00

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
Recruiting
Phase
Not Applicable
Sponsor
Celltrion HealthCare France
Registry
ClinicalTrials.gov
Start date
2 October 2025
Est. completion
1 March 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment.

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: 15 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