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NCT04163016 · ClinicalTrials.gov registry record · Phase 1

A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

A Phase 1 study, sponsored by UCB Biopharma SRL.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT04163016 is a Phase 1 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 22 participants.

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The verdict

NCT04163016, a Phase 1 study, has completed, sponsored by UCB Biopharma SRL.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.

Interventions

  • DRUG Pharmacokinetics of certolizumab pegol

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2020-06-19
Est. Completion 2023-05-23
Phase Phase 1

Sponsor

UCB Biopharma SRL

82 total trials

What the Registry Record Tells You About NCT04163016

The ClinicalTrials.gov registry entry for NCT04163016 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Biopharma SRL, which has 82 total studies on file at ClinicalTrials.gov.

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

NCT04163016 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04163016 about?

NCT04163016 is a clinical study titled "A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)". The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.

What is the current status of trial NCT04163016?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-06-19. Estimated completion is 2023-05-23.

What interventions are being tested in trial NCT04163016?

The interventions under investigation include: Pharmacokinetics of certolizumab pegol (DRUG).

Who is sponsoring clinical trial NCT04163016?

This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.