Trial · NCT04697069
A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
NCT04697069, Phase 2, Terminated, Vanda Pharmaceuticals; results first posted 2023-01-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash. Trials, record NCT04697069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04697069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
- NCT number
- NCT04697069
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Vanda Pharmaceuticals
- Conditions
- Acneiform Eruptions
- Interventions
- Imsidolimab, Placebo
- First posted
- 2021-01-06
- Last updated
- 2025-09-22
- Other registries' IDs
- eudract:2020-003494-22
- Results first posted
- 2023-01-09
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 Count (Papules and Pustules) at Week 8 | Baseline, Week 8 | The number of facial inflammatory lesions (papules and pustules) on the face (excluding the neck and scalp area) was counted. Papule was a small, solid elevation 5 millimeters (mm) or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate. |
| Secondary | Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8 | Baseline, Week 8 | The number of facial inflammatory lesions (papules and pustules) on the face (excluding the neck and scalp area) was counted. Papule was a small, solid elevation 5 mm or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate. |
| Secondary | Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Common Terminology Criteria for Adverse Events (CTCAE) Grading Scale at Week 8 | Baseline, Week 8 | The acneiform rash CTCAE grading scale of severity was 6-point scale ranging from 0-5. Scale 0=no evidence of rash. Scale 1= papules and/or pustules covering \<10% body surface area (BSA), which may or may not be associated with symptoms of pruritus or tenderness. Scale 2=papules and/or pustules covering 10-30% BSA, which may or may not be associated with symptoms of pruritus or tenderness; associated with psychosocial impact; limiting instrumental activities of daily living (ADL); papules and/or pustules covering \>30% BSA with or without mild symptoms. Scale 3=papules and/or pustules covering \>30% BSA with moderate or severe symptoms; limiting self-care ADL; associated with local superinfection with oral antibiotics. Scale 4=life-threatening consequences; papules and/or pustules covering any %BSA, which may or may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with intravenous (IV) antibiotics indicated. Scale 5=death. |
| Secondary | Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale | Baseline up to 55 days | Time to first response of 1 grade improvement from baseline on the acneiform rash CTCAE grading scale: Date of the first response of 1 grade improvement from baseline on the acneiform rash CTCAE grading scale - Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1. |
| Secondary | Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified Multinational Association for Supportive Care in Cancer (MASCC) EGFRi Skin Toxicity Tool (MESTT) Grading Scale (Total Score) at Week 8 | Baseline, Week 8 | The MESTT grading scale of the acneiform rash severity was a 3-point scale ranging from 1 to 3: Scale 1 = 1A: papules or pustules ≤5; OR 1 area of erythema or edema \<1 centimeter (cm) in size. 1B: papules or pustules ≤5; OR 1 area of erythema or edema \<1 cm in size; AND pain or pruritus. Scale 2 = 2A: papules or pustules 6-20; OR 2-5 areas of erythema or edema \<1 cm in size. 2B: Papules or pustules 6-20; OR 2-5 areas of erythema or edema \<1 cm in size; AND pain, pruritus, or effect on emotions or functioning. Scale 3 = 3A: papules or pustules \> 20; OR more than 5 areas of erythema or edema \<1 cm in size. 3B: papules or pustules \> 20; OR more than 5 areas of erythema or edema \<1 cm in size; AND pain, pruritus, or effect on emotions or functioning. Grading was performed individually for the face, scalp, chest, and back. The sum of all body region scores yielded the total score (range: 4 to 12). |
| Secondary | Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score) | Baseline to 55 days | Time to first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (total score): Date of onset of the first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (total score) - Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1. |
| Secondary | Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) at Week 8 | Baseline, Week 8 | The MESTT grading scale of the acneiform rash severity was a 3-point scale ranging from 1 to 3: Scale 1 = 1A: papules or pustules ≤5; OR 1 area of erythema or edema \<1cm in size. 1B: papules or pustules ≤5; OR 1 area of erythema or edema \<1 cm in size; AND pain or pruritus. Scale 2 = 2A: papules or pustules 6-20; OR 2-5 areas of erythema or edema \<1 cm in size. 2B: Papules or pustules 6-20; OR 2-5 areas of erythema or edema \<1 cm in size; AND pain, pruritus, or effect on emotions or functioning. Scale 3 = 3A: papules or pustules \> 20; OR more than 5 areas of erythema or edema \<1 cm in size. 3B: papules or pustules \> 20; OR more than 5 areas of erythema or edema \<1 cm in size; AND pain, pruritus, or effect on emotions or functioning. Grading was performed individually for the face. The score ranged from 1 to 3. |
| Secondary | Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) | Baseline to 55 days | Time to first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (facial assessment): Date of onset of the first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (facial assessment) - Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1. |
| Secondary | Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8 | Baseline, Week 8 | The intensity of pruritus was evaluated by asking participants to assign a numerical score representing the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. |
| Secondary | Percent Change From Baseline in Pruritus NRS at Week 8 | Baseline, Week 8 | The intensity of pruritus was evaluated by asking participants to assign a numerical score representing the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. |
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 Count (Papules and Pustules) at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Common Terminology Criteria for Adverse Events (CTCAE) Grading Scale at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale | Baseline up to 55 days | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified Multinational Association for Supportive Care in Cancer (MASCC) EGFRi Skin Toxicity Tool (MESTT) Grading Scale (Total Score) at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score) | Baseline to 55 days | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) | Baseline to 55 days | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. | ||
| SECONDARY | Percent Change From Baseline in Pruritus NRS at Week 8 | Baseline, Week 8 | Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Imsidolimab | Any TEAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Placebo | Any TEAEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Imsidolimab | Serious TEAEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Placebo | Serious TEAEs | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imsidolimab | 2 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | COMPLETED | Imsidolimab | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Imsidolimab | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events6
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 | Diarrhoea | Gastrointestinal disorders | Imsidolimab | 0 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 2 | |
| other | Electrocardiogram T wave inversion | Investigations | Imsidolimab | 0 | 2 | |
| other | Electrocardiogram T wave inversion | Investigations | Placebo | 1 | 2 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Imsidolimab | 0 | 2 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Placebo | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imsidolimab | 0 | 2 |
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, other adverse events | Imsidolimab | 0 | 2 |
| Total, other adverse events | Placebo | 2 | 2 |
| Total, serious adverse events | Imsidolimab | 0 | 2 |
| Total, serious adverse events | Placebo | 0 | 2 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Imsidolimab vs Placebo: deaths from any cause | Trial comparisons |
| Imsidolimab vs Placebo: serious adverse events | Trial comparisons |
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/NCT04697069
GET https://conductscience.org/api/trials/v1/NCT04697069/registered