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Supporting Continued Access After Clinical Trials
argenx is committed to supporting patients throughout the clinical research journey, including through Post-Trial Access (PTA) programs for eligible participants following completion of a clinical trial.
The Principal Investigator may request PTA for patients who were actively enrolled in an argenx clinical trial, immediately following the end of the study, if the patients will experience a temporary treatment gap until the medication is approved and reimbursed in their country.
The clinical trial physician must submit a written request for access for patients who are deriving benefit and do not have an alternative treatment option available to them in their country.
Criteria for Requests
Post-Trial Access Principles
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Serious Medical Need |
The participant has a serious or immediately life-threatening condition, has no other suitable treatment options available, and does not qualify for another ongoing clinical trial. |
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Limited Availability |
The medicine is not yet approved or commercially available for the indication, or is not available by other means in the country where the trial was conducted. |
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Investigator Request |
The request for PTA was made by the clinical trial principal investigator in writing. |
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Prior Trial Participation |
The participant was part of a clinical trial in which the medicine was administered immediately following the end of active clinical trial participation. |
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Benefit-Risk Review |
The risks and benefits of using the medicine in the particular disease or condition indicate a favorable risk-benefit assessment for the individual based on the investigator’s evaluation of the participant’s response to the intervention, in consultation with argenx. |
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Supply Availability |
argenx has an adequate supply of product to provide to the patient and, if applicable, to support ongoing clinical trials that are critical to getting the new treatment approved and thereby reach the broadest possible patient population. |
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Commercial Intent |
argenx will only consider a PTA request in a country where there is a bona fide intent for commercialization after PTA. |
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Regulatory Compliance |
A request for PTA to a product is in compliance with all local laws and regulations and access within the PTA is temporary until the product is commercially available. |
Post-Trial Access Request
To request PTA, the licensed treating physician should submit a request to PAATeam@argenx.com. Requests for treatment will be acknowledged and reviewed expeditiously by the argenx Medical Team. argenx is committed to responding promptly to all inquiries received about PTA; inquiries will be addressed within five business days.
If a request for Post-Trial Access is approved by argenx, the physician may also need to obtain Health Authority approval in that country prior to access to the investigational therapy.
If new information becomes known about the investigational product, the ongoing health of the individual, and/or market availability of the product or alternative therapies, PTA may end with clear communication the investigator and patient.
Explore More
At argenx, every piece of the innovation story connects. See where it leads next.
Clinical Trials
Discover argenx-sponsored clinical trials currently underway.
Pre-Approval Access
Read about the criteria for submitting a pre-approval access request.
Clinical Research Guide
Realizing why someone would choose to participate can help you make your own decision.
