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NCT03738423 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

A Phase 2 study, sponsored by Regeneron Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
129
Enrollment target

NCT03738423: Clinical Trial Phase 2 study, sponsored by Regeneron Pharmaceuticals.

NCT03738423 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03738423, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
129 participants
Enrollment target

Study Summary

The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: * Assess the safety and tolerability of subcutaneous (SC) doses of REGN3500 monotherapy in adult patients with moderate-to-severe AD * Assess the Pharmacokinetics (PK) of REGN3500 in adult patients with moderate-to-severe AD * Assess the immunogenicity of REGN3500 in adult patients with moderate-to-severe AD

Primary Outcome

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing.

Interventions

  • DRUG REGN3500
  • DRUG REGN3500-Matching Placebo

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2018-11-13
Est. Completion 2020-07-24
Phase Phase 2
Regeneron Pharmaceuticals

280 total trials

Why NCT03738423 stopped before completion

NCT03738423 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which REGN3500 is the first listed.

NCT03738423 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03738423 about?

NCT03738423 is a clinical study titled "Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis". The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD. Secondary objectives are to: * Assess the safety and ...

What is the current status of trial NCT03738423?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2018-11-13. Estimated completion is 2020-07-24.

What interventions are being tested in trial NCT03738423?

The interventions under investigation include: REGN3500 (DRUG), REGN3500-Matching Placebo (DRUG).

Who is sponsoring clinical trial NCT03738423?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03738423's enrollment target sits among peer trials

129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03738423, the US trial registry maintained by the National Library of Medicine. NCT03738423 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.