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Long-term extension study of ligelizumab in food allergy
EU CTIS ID: 2022-502366-25-00
What this study is testing
To evaluate the long-term safety and tolerability of ligelizumab in participants with food allergy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit
- Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy (e.g., Study CQGE031G12301). Please refer to the Section 4.1 for the timing of transition.
- Participants who are willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge)
- Participants who agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout this study
- Participants who are able to safely continue into the study as judged by the investigator
You likely can't join if
- Development of a severe or life threatening episode of an allergic reaction that required intubation and/or ICU admission during the core studies
- Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core study
- Development of uncontrolled asthma during the core study that could compromise the safety of the participants judged by the investigator
- Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator
- Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion they should not participate in this extension study
- Platelets <75,000/ul at EoT of the core study
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- United Kingdom
- Japan
- Canada
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; United Kingdom; Japan; Canada; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.