Trial · NCT04856917
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
NCT04856917, Phase 2, Completed, Vanda Pharmaceuticals; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris. Trials, record NCT04856917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04856917
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
- NCT number
- NCT04856917
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Acne Vulgaris
- Interventions
- Imsidolimab, Placebo
- First posted
- 2021-04-23
- Last updated
- 2025-09-22
- Results first posted
- 2023-06-15
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | 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. |
| Secondary | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Baseline, 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. |
| Secondary | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
| Secondary | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
| Secondary | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
| Secondary | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
| Secondary | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
| Secondary | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
| Secondary | 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 | Baseline, 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. |
| Secondary | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Baseline, 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Baseline, Week 12 | Participants in ITT Analysis Set with available data were analyzed. | lesions | MEAN |
| SECONDARY | Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Baseline, Weeks 2, 4, 8, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | lesions | MEAN |
| SECONDARY | Percent Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12 and 20 | Participants in the ITT Analysis Set with available data were analyzed. | percent change | MEAN |
| SECONDARY | Change From Baseline in Facial Non-inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | lesions | MEAN |
| SECONDARY | Percent Change From Baseline in Facial Non-Inflammatory Lesion Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | percent change | MEAN |
| SECONDARY | Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | lesions | MEAN |
| SECONDARY | Percent Change From Baseline in Total Facial Lesion (Inflammatory and Non-inflammatory Lesions) Counts at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | percent change | MEAN |
| SECONDARY | Change From Baseline in Facial Investigator's Global Assessment (IGA) at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | units on a scale | MEAN |
| SECONDARY | 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 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each Response Category for the Patient Global Impression of Severity (PGI-S) at Weeks 2, 4, 8, 12, and 20 | Baseline, Weeks 2, 4, 8, 12, and 20 | Participants in the ITT Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group321
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Imsidolimab 400/200 mg | -6.8 | Standard Deviation 13.63 | lesions | |
| Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Imsidolimab 200/100 mg | -7.4 | Standard Deviation 16.38 | lesions | |
| Change From Baseline in Facial Inflammatory Lesion Counts at Week 12 | Placebo | -9.6 | Standard Deviation 10.66 | lesions | |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Imsidolimab 400/200 mg | Change at Week 2 | -1.9 | Standard Deviation 7.87 | lesions |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Imsidolimab 200/100 mg | Change at Week 2 | -0.5 | Standard Deviation 7.30 | lesions |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Placebo | Change at Week 2 | -3.8 | Standard Deviation 7.04 | lesions |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Imsidolimab 400/200 mg | Change at Week 4 | -0.3 | Standard Deviation 15.21 | lesions |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Imsidolimab 200/100 mg | Change at Week 4 | -4.4 | Standard Deviation 9.87 | lesions |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Placebo | Change at Week 4 | -8.0 | Standard Deviation 9.64 | lesions |
| Change From Baseline in Facial Inflammatory Lesion Counts at Weeks 2, 4, 8, and 20 | Imsidolimab 400/200 mg | Change at Week 8 | -5.5 | Standard Deviation 10.75 | lesions |
1 to 10 of 321Source ClinicalTrials.gov
See all 321 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imsidolimab 400/200 mg | 42 | |
| Overall Study | STARTED | Imsidolimab 200/100 mg | 40 | |
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | Safety Analysis Set | Imsidolimab 400/200 mg | 41 | |
| Overall Study | Safety Analysis Set | Imsidolimab 200/100 mg | 39 | |
| Overall Study | Safety Analysis Set | Placebo | 41 | |
| Overall Study | COMPLETED | Imsidolimab 400/200 mg | 34 | |
| Overall Study | COMPLETED | Imsidolimab 200/100 mg | 34 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Imsidolimab 400/200 mg | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Imsidolimab 400/200 mg | 3 | 41 | |
| other | COVID-19 | Infections and infestations | Imsidolimab 200/100 mg | 1 | 39 | |
| other | COVID-19 | Infections and infestations | Placebo | 5 | 41 | |
| other | Upper respiratory tract infection | Infections and infestations | Imsidolimab 400/200 mg | 3 | 41 | |
| other | Upper respiratory tract infection | Infections and infestations | Imsidolimab 200/100 mg | 1 | 39 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 41 | |
| other | Blood creatine phosphokinase increased | Investigations | Imsidolimab 400/200 mg | 0 | 41 | |
| other | Blood creatine phosphokinase increased | Investigations | Imsidolimab 200/100 mg | 2 | 39 | |
| other | Blood creatine phosphokinase increased | Investigations | Placebo | 1 | 41 | |
| other | Headache | Nervous system disorders | Imsidolimab 400/200 mg | 3 | 41 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imsidolimab 400/200 mg | 0 | 42 |
| Total, all-cause mortality | Imsidolimab 200/100 mg | 0 | 40 |
| Total, all-cause mortality | Placebo | 0 | 41 |
| Total, other adverse events | Imsidolimab 400/200 mg | 8 | 41 |
| Total, other adverse events | Imsidolimab 200/100 mg | 6 | 39 |
| Total, other adverse events | Placebo | 6 | 41 |
| Total, serious adverse events | Imsidolimab 400/200 mg | 1 | 41 |
| Total, serious adverse events | Imsidolimab 200/100 mg | 0 | 39 |
| Total, serious adverse events | Placebo | 0 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04856917
GET https://conductscience.org/api/trials/v1/NCT04856917/results?page=2