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Could a Lab-Made antibody be the next acne breakthrough?

NCT ID NCT04856917

Disease control Sponsor: Vanda Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 trial tested a drug called imsidolimab (ANB019) in 123 people with moderate to severe acne. The drug is a lab-made antibody designed to reduce inflammation. Researchers measured how much facial acne lesions decreased over 12 weeks compared to a placebo. The goal is to see if this treatment is safe and effective for acne.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
imsidolimab (ANB019), a lab-made antibody
What this could lead to
If it works, this could offer a new treatment option for people with moderate to severe acne who don't respond to current therapies.
What could go wrong
This is an early Phase 2 trial with only 123 participants, so results may not apply to everyone. The drug may not reduce acne better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

123 people

The number who actually took part.

Started

May 2021

Finished

Mar 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Diagnosis of moderate to severe facial AV * Facial IGA) score of 3 (moderate) or 4 (severe) * At least 20 and no more than 100 inflammatory lesions on the face * No more than 100 non-inflammatory lesions on the face. * No more than 5 nodules (≥5 millimeter \[mm\]) on the face Key Exclusion Criteria: * A participant with acne fulminans or conglobate or secondary acne will be excluded.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne vulgaris

Contacts and locations

Locations

  • Site 10-101

    San Antonio, Texas, 78213, United States

  • Site 10-102

    College Station, Texas, 77845, United States

  • Site 10-103

    Austin, Texas, 78759, United States

  • Site 10-104

    Detroit, Michigan, 48202, United States

  • Site 10-105

    Murfreesboro, Tennessee, 37130, United States

  • Site 10-106

    Sherman Oaks, California, 91403, United States

  • Site 10-107

    Tampa, Florida, 33613, United States

  • Site 10-108

    Tampa, Florida, 33607, United States

  • Site 10-109

    New Orleans, Louisiana, 70119, United States

  • Site 10-110

    Portsmouth, New Hampshire, 03801, United States

  • Site 10-111

    Fountain Valley, California, 92708, United States

  • Site 10-112

    New Orleans, Louisiana, 70119, United States

  • Site 10-113

    Sweetwater, Florida, 33172, United States

  • Site 10-114

    Hot Springs, Arkansas, 71913, United States

  • Site 10-115

    Waterloo, Ontario, N2J1C4, Canada

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