Trial · NCT04499235
A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
NCT04499235, Phase 2, Terminated, Alkahest, Inc.; results first posted 2023-09-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid. Trials, record NCT04499235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04499235
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
- NCT number
- NCT04499235
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Alkahest, Inc.
- Conditions
- Pemphigoid, Bullous
- Interventions
- Mometasone furoate, AKST4290, Placebo
- First posted
- 2020-08-05
- Last updated
- 2023-09-14
- Results first posted
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy | Baseline to up to 3 weeks (until disease control) | Disease control is defined as ≤ 3 new blisters/eczematous lesions/urticarial plaques/day and healing of existing blisters/eczematous lesions/urticarial plaques without requiring rescue therapy. |
| Secondary | Number of Participants With TEAEs, Assessed by Seriousness and Severity | Baseline to 5 weeks | Treatment-emergent AEs summarized by MedDRA coding terms; separate tabulations produced for incidence, seriousness and severity of AEs |
| Secondary | Time to Disease Control | Baseline to up to 3 weeks (until disease control) | Time to disease control by treatment day/week. The time to disease control is calculated as the date of disease control minus Date of Visit 2 (Baseline (Day 1)) plus 1. |
| Secondary | Time to Rescue Therapy | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Time to rescue therapy by treatment day/week. The time to rescue therapy is calculated as the start date of the first rescue therapy minus Date of Visit 2 (Baseline (Day 1)) plus 1. |
| Secondary | The Bullous Pemphigoid Disease Area Index (BPDAI) Score | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Change from baseline in BPDAI score at End of Treatment (EOT). Subscales for the BPDAI include the skin blister score (range 0-120), skin urticarial score (range 0-120), mucosal activity score (range 0-120), and damage score (range 0-12). Higher scores indicate greater disease activity or damage. |
| Secondary | The Bullous Pemphigoid Disease Area Index Visual Analog Scale (BPDAI-VAS) | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Change from baseline in pruritus as evaluated by the BPDAI-VAS at End of Treatment (EOT). EOT occurs at disease control (up to 3 weeks) or at Week 3 when the subject is discontinued from treatment due to not reaching disease control. Scores for the BPDAI-VAS can range from 0 to 30, with higher scores indicating a worse condition. |
| Secondary | Total Cumulative Steroid Exposure | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Total cumulative steroid exposure (cortisol equivalent/kg) by treatment group |
| Secondary | Maximum Daily Steroid Dose | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Evaluation of maximum daily steroid dose at baseline, by treatment week, and at disease control. Study Day 1 is defined as the initiation of study treatment. 1 mg/kg prednisolon(e) = 5 mg/kg cortisone. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy | Baseline to up to 3 weeks (until disease control) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With TEAEs, Assessed by Seriousness and Severity | Baseline to 5 weeks | The Safety Evaluable Set includes all randomized subjects who receive at least 1 dose of the study agent (AKST4290 or placebo) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Disease Control | Baseline to up to 3 weeks (until disease control) | Analysis population includes subjects who achieved disease control with and without rescue therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Rescue Therapy | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Bullous Pemphigoid Disease Area Index (BPDAI) Score | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | score on a scale | MEAN | |
| SECONDARY | The Bullous Pemphigoid Disease Area Index Visual Analog Scale (BPDAI-VAS) | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | score on a scale | MEAN | |
| SECONDARY | Total Cumulative Steroid Exposure | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | Total cumulative steroid exposure is calculated based on oral route treatment from Day 1 to EOT/disease control. Subjects with no oral route treatment were excluded from analysis. | mg cortisol equivalent/kg | MEAN |
| SECONDARY | Maximum Daily Steroid Dose | Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control. | The analysis population includes subjects who received systemic steroids. In the AKST4290 group, 3 subjects received systemic steroids. In the Placebo group, the single subject did not have systemic steroid exposure. | mg cortisol equivalent/kg | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy | Mometasone Furoate + AKST4290 | 2 | Participants | ||
| The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy | Mometasone Furoate + Placebo | 1 | Participants | ||
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + AKST4290 | Subjects Reporting at Least One TEAE | 2 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + Placebo | Subjects Reporting at Least One TEAE | 1 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + AKST4290 | Subjects Reporting at Least One Serious TEAE | 0 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + Placebo | Subjects Reporting at Least One Serious TEAE | 1 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + AKST4290 | TEAE by Severity: Mild | 2 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + Placebo | TEAE by Severity: Mild | 0 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + AKST4290 | TEAE by Severity: Moderate | 0 | Participants | |
| Number of Participants With TEAEs, Assessed by Seriousness and Severity | Mometasone Furoate + Placebo | TEAE by Severity: Moderate | 0 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mometasone Furoate + AKST4290 | 5 | |
| Overall Study | STARTED | Mometasone Furoate + Placebo | 1 | |
| Overall Study | COMPLETED | Mometasone Furoate + AKST4290 | 5 | |
| Overall Study | COMPLETED | Mometasone Furoate + Placebo | 1 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate + AKST4290 | 0 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate + Placebo | 0 |
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 | Blood potassium decreased | Investigations | Mometasone Furoate + AKST4290 | 1 | 5 | 1 |
| other | Blood potassium decreased | Investigations | Mometasone Furoate + Placebo | 0 | 1 | 0 |
| other | Rash | Skin and subcutaneous tissue disorders | Mometasone Furoate + AKST4290 | 1 | 5 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Mometasone Furoate + Placebo | 0 | 1 | 0 |
| serious | COVID-19 | Infections and infestations | Mometasone Furoate + AKST4290 | 0 | 5 | 0 |
| serious | COVID-19 | Infections and infestations | Mometasone Furoate + Placebo | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mometasone Furoate + AKST4290 | 0 | 5 |
| Total, all-cause mortality | Mometasone Furoate + Placebo | 1 | 1 |
| Total, other adverse events | Mometasone Furoate + AKST4290 | 2 | 5 |
| Total, other adverse events | Mometasone Furoate + Placebo | 0 | 1 |
| Total, serious adverse events | Mometasone Furoate + AKST4290 | 0 | 5 |
| Total, serious adverse events | Mometasone Furoate + Placebo | 1 | 1 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mometasone Furoate + AKST4290 vs Mometasone Furoate + Placebo: The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy | Trial comparisons |
| Mometasone Furoate + AKST4290 vs Mometasone Furoate + Placebo: deaths from any cause | Trial comparisons |
| Mometasone Furoate + AKST4290 vs Mometasone Furoate + 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/NCT04499235
GET https://conductscience.org/api/trials/v1/NCT04499235/results?page=2