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NCT04080206 · ClinicalTrials.gov registry record · Phase 2

A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

A Phase 2 study, sponsored by Therapeutics.

Completed
Registry status
Phase 2
Development phase
55
Enrollment target

NCT04080206: Completed Phase 2 study, sponsored by Therapeutics.

NCT04080206 is a Phase 2 study that has completed, run by Therapeutics. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04080206, a Phase 2 study, has completed, sponsored by Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
55 participants
Enrollment target

Study Summary

Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.

Primary Outcome

A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).

Interventions

  • DRUG 188-0551 Spray
  • DRUG RLD

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2020-04-07
Est. Completion 2021-01-20
Phase Phase 2
Therapeutics

17 total trials

What the finished NCT04080206 record still lists

NCT04080206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).

The record links to 0 conditions, and to 2 interventions - of which 188-0551 Spray is the first listed.

NCT04080206 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04080206 about?

NCT04080206 is a clinical study titled "A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis". Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Ref...

What is the current status of trial NCT04080206?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2020-04-07. Estimated completion is 2021-01-20.

What interventions are being tested in trial NCT04080206?

The interventions under investigation include: 188-0551 Spray (DRUG), RLD (DRUG).

Who is sponsoring clinical trial NCT04080206?

This trial is sponsored by Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04080206's enrollment target sits among peer trials

55 1153rd of 2000 higher than 841 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 NCT04080206, the US trial registry maintained by the National Library of Medicine. NCT04080206 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.