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NCT03075904 · ClinicalTrials.gov registry record · Phase 1

A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)

A Phase 1 study, sponsored by Alexion Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
8
Enrollment target

NCT03075904: Clinical Trial Phase 1 study, sponsored by Alexion Pharmaceuticals.

NCT03075904 is a Phase 1 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03075904, a Phase 1 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).

Primary Outcome

A TEAE was defined as any adverse event (AE) that starts on or after the first dose of study drug or occurs prior to the first dose and worsens in severity on or after the first dose of study drug, during the Treatment Period and Follow-up Period. A TEAE was considered "serious" (Grade 3) if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, life-threatening adverse drug event, inpatient hospitalization or prolongation of existing hospitaliza

Interventions

  • DRUG ALXN1830

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2017-07-18
Est. Completion 2019-01-16
Phase Phase 1
Alexion Pharmaceuticals

162 total trials

Why NCT03075904 stopped before completion

NCT03075904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which ALXN1830 is the first listed.

NCT03075904 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03075904 about?

NCT03075904 is a clinical study titled "A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)". This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).

What is the current status of trial NCT03075904?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2017-07-18. Estimated completion is 2019-01-16.

What interventions are being tested in trial NCT03075904?

The interventions under investigation include: ALXN1830 (DRUG).

Who is sponsoring clinical trial NCT03075904?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03075904's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03075904, the US trial registry maintained by the National Library of Medicine. NCT03075904 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.