Acne VulgarisPhase 2NCT04856917
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
A Phase 2 study testing Imsidolimab in people with Acne Vulgaris, run by Vanda Pharmaceuticals at 15 sites in 2 countries.
Trial summary
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Imsidolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 15 May 2021to 29 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- A participant with acne fulminans or conglobate or secondary acne will be excluded.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Site 10-103
Austin, Texas, 78759
Site 10-102
College Station, Texas, 77845
Site 10-104
Detroit, Michigan, 48202
Site 10-111
Fountain Valley, California, 92708
Site 10-114
Hot Springs, Arkansas, 71913
Site 10-105
Murfreesboro, Tennessee, 37130
Site 10-109
New Orleans, Louisiana, 70119
Site 10-112
New Orleans, Louisiana, 70119
Site 10-110
Portsmouth, New Hampshire, 03801
Site 10-101
San Antonio, Texas, 78213
Site 10-106
Sherman Oaks, California, 91403
Site 10-113
Sweetwater, Florida, 33172
Site 10-108
Tampa, Florida, 33607
Site 10-107
Tampa, Florida, 33613
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with AV.
- Conditions
- Acne Vulgaris
- Being tested
- Imsidolimab, Placebo
- Keywords
- LI-36 Receptor, Interleukin 36, Imsidolimab
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImsidolimabDrug
Also called ANB019
Humanized Monoclonal Antibody
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Imsidolimab 400/200 mg | Experimental | Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57. Receives: Drug: Imsidolimab |
| Imsidolimab 200/100 mg | Experimental | Participants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. Receives: Drug: Imsidolimab |
| Placebo | Placebo comparator | Participants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Week 12
Secondary outcomes (13)
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Weeks 2, 4, 8, and 20
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Weeks 2, 4, 8, 12 and 20
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
The number of facial non-inflammatory lesions (open and closed comedones) on the forehead, left and right cheeks, and chin was counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
The number of facial inflammatory (pustules, papules, and nodular lesions) and non-inflammatory (open and closed comedones) lesions on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
The Facial IGA was a global assessment that was used to assess the current state of acne vulgaris (AV) on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe).
Clear (0): clear skin with no inflammatory or non-inflammatory lesions
Almost Clear (1): A few scattered comedowns and a few small papules
Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules
Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present
Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present.
The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20
The Facial IGA was a global assessment that was used to assess the current state of AV on the face at each visit. It is a 5-point morphological assessment ranging from 0 (clear) to 4 (severe).
Clear (0): clear skin with no inflammatory or non-inflammatory lesions
Almost Clear (1): A few scattered comedowns and a few small papules
Mild (2): Easily recognizable; less than half the surface is involved. some comedowns and some papules and pustules
Moderate (3): More than half of the surface is involved. Many comedowns, papules, and pustules. One nodule may be present
Severe (4): Entire surface is involved. Covered with comedowns, numerous papules and pustules. Few nodules may be present.
The Facial IGA was an overall global evaluation that was performed at an arm's length distance from the participant and must be performed before the acne lesion count.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
PGI- S was a single-item question, which asks the participant to rate the current severity of AV. The response options were:
Clear Skin (1)
Mild (2)
Moderate (3)
Severe (4)
Higher score indicated more severity.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
PGI-C was a single-item, self-administered questionnaire, which asked the participant to rate the change in their symptom severity. Scores ranged from 1 (Very much better) to 7 (Very much worse).
Very much better (1)
Much better (2)
A little better (3)
No change (4)
A little worse (5)
Much worse (6)
Very much worse (7)
Higher score indicated more severity.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
DLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The DLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The DLQI was administered to participants ≥ 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
CDLQI was a simple 10-question validated questionnaire, each question was scored from 0 (not relevant/not at all) to 3 (very much). The CDLQI total score ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life). The aim of this participant-reported questionnaire was to measure how much the skin condition had affected the participant's quality of life. The CDLQI was administered to participants < 16 years of age. Participants were administered the same questionnaire during the entire study based on their age at Day 1.
Measured: Baseline, Weeks 2, 4, 8, 12, and 20
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment that did not necessarily have a causal relationship with treatment. An AE was considered "serious" if it resulted in death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. TEAE was defined as a new event that occurred during or after first dose of study treatment or any event present at baseline that worsens in either intensity or frequency after first dose of study treatment.
Measured: First dose of study drug until end of study (up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start15 May 2021
- Primary completion1 Feb 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856917
- Sponsor's protocol ID
- ANB019-209
- Status last verified
- May 2023
- First submitted
- 20 Apr 2021
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04856917
- Acronym / sponsor ID
- ANB019-209
- Conditions
- Acne Vulgaris
- Keywords
- LI-36 Receptor, Interleukin 36, Imsidolimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab in adolescent and adult participants with acne vulgaris (AV). This study also will characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with AV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imsidolimab 400/200 mg | Experimental | Drug: ImsidolimabParticipants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57. |
| Imsidolimab 200/100 mg | Experimental | Drug: ImsidolimabParticipants received imsidolimab 200 mg by SC injection on Day 1, followed by 100 mg on Days 29 and 57. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants received imsidolimab matching placebo by SC injection on Days 1, 29, and 57. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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 (1 listed)
- A participant with acne fulminans or conglobate or secondary acne will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImsidolimabAlso: ANB019Humanized Monoclonal Antibody | Drug | Imsidolimab 200/100 mg, Imsidolimab 400/200 mg |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Time frame: Baseline, Week 12
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
13 secondary outcomes
Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20
Time frame: Baseline, Weeks 2, 4, 8, and 20
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12 and 20
Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Percentage of Participants Achieving a Facial IGA of Clear (0) or Almost Clear (1) With at Least a 2-grade Decrease From Baseline at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Percentage of Participants in Each Response Category for the Patient Global Impression of Change (PGI-C) at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Dermatology Life Quality Index Questionnaire (DLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Weeks 2, 4, 8, 12, and 20
Time frame: Baseline, Weeks 2, 4, 8, 12, and 20
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: First dose of study drug until end of study (up to 20 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imsidolimab in people with Acne Vulgaris, run by Vanda Pharmaceuticals at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.