Trial · NCT04491604
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
NCT04491604, Phase 3, Completed, Krystal Biotech, Inc.; results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB. Trials, record NCT04491604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04491604
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
- NCT number
- NCT04491604
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Krystal Biotech, Inc.
- Conditions
- Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
- Interventions
- Topical Beremagene Geperpavec, Placebo
- First posted
- 2020-07-29
- Last updated
- 2023-02-17
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 22 and 24 or Weeks 24 and 26 | 26 weeks post-baseline | The primary wound was defined as a responder wound that met either of the following conditions: * Complete wound healing on Week 22 and Week 24, or * Complete wound healing on Week 24 and Week 26. For subjects with missing primary wound healing data, a multiple imputation approach (10 repliates) was used. The total numbers of primary wounds with complete healing for B-VEC and Placebo presented below were the average of those from the multiple imputation replicates, and therefore, they would not be whole numbers (integers). |
| Secondary | Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 8 and 10 or Weeks 10 and 12 | 12 weeks post-baseline | The primary wound was defined as a responder wound that met either of the following conditions: * Complete wound healing on Week 8 and Week 10, or * Complete wound healing on Week 10 and Week 12. For subjects with missing primary wound healing data, a multiple imputation approach (10 repliates) was used. The total numbers of primary wounds with complete healing for B-VEC and Placebo presented below were the average of those from the multiple imputation replicates, and therefore, they would not be whole numbers (integers). |
| Secondary | Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | 26 weeks post-baseline | Changes from baseline at Weeks 22, 24, and 26 in primary wound pain severity (visual analog scale (VAS)) for ages 6 and above subjects. The Visual Analog Scale scores from 0 (no pain) to 10 (the worst possible pain). Negative values in changes from baseline mean improvement in pain severity. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 22 and 24 or Weeks 24 and 26 | 26 weeks post-baseline | The intent-to-treat (ITT) population included subjects whose primary wounds were randomized regardless of whether they received randomized treatment or not. | number of wounds with complete healing | NUMBER |
| SECONDARY | Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 8 and 10 or Weeks 10 and 12 | 12 weeks post-baseline | The intent-to-treat (ITT) population included subjects whose primary wounds were randomized regardless of whether they received randomized treatment or not. | number of wounds with complete healing | NUMBER |
| SECONDARY | Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | 26 weeks post-baseline | The intent-to-treat (ITT) population included subjects whose primary wounds were randomized regardless of whether they received randomized treatment or not. For pain severity, only subjects ages 6 and above were evaluated (n=27). The analyses were based on observed data where missing data were not imputed, therefore the numbers of available data for analyses could be less than the total. | score on a scale of 0 to 10 | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 22 and 24 or Weeks 24 and 26 | B-VEC | 20.9 | number of wounds with complete healing | ||
| Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 22 and 24 or Weeks 24 and 26 | Placebo | 6.7 | number of wounds with complete healing | ||
| Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 8 and 10 or Weeks 10 and 12 | B-VEC | 21.9 | number of wounds with complete healing | ||
| Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 8 and 10 or Weeks 10 and 12 | Placebo | 6.1 | number of wounds with complete healing | ||
| Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | B-VEC | Week 22 | -0.88 | Standard Deviation 2.346 | score on a scale of 0 to 10 |
| Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | Placebo | Week 22 | -0.71 | Standard Deviation 2.476 | score on a scale of 0 to 10 |
| Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | B-VEC | Week 24 | -0.64 | Standard Deviation 2.325 | score on a scale of 0 to 10 |
| Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | Placebo | Week 24 | -0.08 | Standard Deviation 2.548 | score on a scale of 0 to 10 |
| Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | B-VEC | Week 26 | -0.63 | Standard Deviation 2.123 | score on a scale of 0 to 10 |
| Primary Wound Pain Severity (Visual Analog Scale (VAS)) Change for Ages 6 and Above Subjects at Weeks 22, 24, and 26. | Placebo | Week 26 | -0.38 | Standard Deviation 2.871 | score on a scale of 0 to 10 |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 31 | 62 |
| Overall Study | B-VEC | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 31 | 31 |
| Overall Study | Placebo | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 31 | 31 |
| Overall Study | COMPLETED | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 28 | 56 |
| Overall Study | NOT COMPLETED | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 3 | 6 |
Source ClinicalTrials.gov
Adverse events11
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 | Pruritus | Skin and subcutaneous tissue disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 3 | 31 | 4 |
| other | Erythema | Skin and subcutaneous tissue disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 2 | 31 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 2 | 31 | 2 |
| other | Chills | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 3 | 31 | 3 |
| other | Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 3 | 31 | 4 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 2 | 31 | 2 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 2 | 31 | 2 |
| serious | Cellulitis | Infections and infestations | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 31 | 1 |
| serious | Diarrhoea | Gastrointestinal disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 31 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 31 | 2 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 0 | 31 |
| Total, other adverse events | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 17 | 31 |
| Total, serious adverse events | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 3 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36516090 | DERIVED |
Source PubMed
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/NCT04491604
GET https://conductscience.org/api/trials/v1/NCT04491604/registered