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NCT05633355 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
187
Enrollment target

NCT05633355: Completed Phase 3 study, sponsored by Amgen.

NCT05633355 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 187 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05633355, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
187 participants
Enrollment target

Study Summary

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Primary Outcome

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the study treatment. A SAE was defined as any untoward medical occurrence that meets at least 1 of the following serious criteria: resulted in death (fatal), was immediately life-threatening, required in-patient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect,

Interventions

  • DRUG Rocatinlimab

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2023-01-30
Est. Completion 2025-07-31
Phase Phase 3
Amgen

558 total trials

What the finished NCT05633355 record still lists

NCT05633355 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).

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

NCT05633355 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05633355 about?

NCT05633355 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)". The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

What is the current status of trial NCT05633355?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2023-01-30. Estimated completion is 2025-07-31.

What interventions are being tested in trial NCT05633355?

The interventions under investigation include: Rocatinlimab (DRUG).

Who is sponsoring clinical trial NCT05633355?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05633355's enrollment target sits among peer trials

187 1410th of 2000 higher than 589 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT05633355, the US trial registry maintained by the National Library of Medicine. NCT05633355 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.