Phase 4 Rare Disease Trial, Recruiting NCT07142343 Sponsor: Regeneron Pharmaceuticals Condition: Rare Disease
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Phase 4 Rare Disease Trial, Recruiting

NCT07142343
Recruiting Phase 4

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:

  • The participant must have been clinically diagnosed with CD55-deficient CHAPLE disease, as defined by the trial protocol.
  • The participant's parent(s) or legal guardian(s) must be willing and able to attend clinic visits and follow all study procedures, including ensuring the participant completes the full series of meningococcal vaccinations required by the trial.
  • The participant's parent(s) or legal guardian(s) must be willing to provide written consent for the participant to take part.
  • The participant must currently have active CHAPLE disease, as defined by the trial protocol.

Who may not be able to join:

  • People who have previously had a meningococcal infection.
  • People who have not received a documented meningococcal quadrivalent (ACWY) vaccination before the screening visit, if the participant's parent(s) or legal guardian(s) are unwilling for the participant to receive this vaccination during the study.
  • People who have not received documented vaccinations for Haemophilus influenzae and Streptococcus pneumoniae before the screening visit, where those vaccinations are recommended under local guidelines (confirm with trial site).
  • People who have previously been treated with a complement inhibitor medication, as defined by the trial protocol (confirm with trial site).
  • People who have another condition that causes low protein levels in the blood or a secondary condition affecting the lymphatic vessels of the intestine (confirm with trial site).

Important: Additional inclusion and exclusion criteria not listed here may also apply. 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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Clinical Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

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
Phase 4
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
19 March 2026
Est. completion
12 February 2030

Where this trial is recruiting

Turkey (Türkiye)

Primary endpoints

Incidence of Treatment-Emergent Adverse Event (TEAEs); Severity of TEAEs

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: 28 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