Trial · NCT03536143
A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients
NCT03536143, Phase 1, Phase 2, Completed, Krystal Biotech, Inc.; results first posted 2023-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients. Trials, record NCT03536143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03536143
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients
- NCT number
- NCT03536143
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Krystal Biotech, Inc.
- Conditions
- Dystrophic Epidermolysis Bullosa
- Interventions
- Topical beremagene geperpavec, Placebo gel
- First posted
- 2018-05-24
- Last updated
- 2023-01-31
- Results first posted
- 2023-01-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reported at Least One Adverse Event, Safety Population | baseline to 12 weeks | Safety assessments included evaluation of medical and medication history, physical / skin examination, vital signs, adverse events, and laboratory evaluations. Due to the 'split-person' intrasubject design, the safety assessments were reported at subject level, but not per intervention. |
| Primary | Number of Adverse Events Reported, Safety Population | baseline to 12 weeks | Safety assessments included evaluation of medical and medication history, physical / skin examination, vital signs, adverse events, and laboratory evaluations. Due to the 'split-person' intrasubject design, the safety assessments were reported at subject level, but not per intervention. |
| Primary | Complete Wound Closure Responder, ITT Population | from baseline at Weeks 8, 10, and 12 | One wound is a responder if the reduction from baseline in wound surface is ≥90%. |
| Primary | Time to Wound Closure Analysis, ITT Population | baseline to complete wound closure | Time to wound closure was defined as the time from the first treatment to Complete Wound Closure (≥90% reduction in wound surface area from baseline) |
| Primary | Duration of Wound Closure, ITT Population | Time from the complete closure to the first reopening of the same wound | Duration of wound closure |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reported at Least One Adverse Event, Safety Population | baseline to 12 weeks | Safety population included all subjects administered B-VEC or Placebo. Due to the 'split-person' intrasubject design, the safety assessments were reported at subject level, but not per intervention. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Adverse Events Reported, Safety Population | baseline to 12 weeks | Safety population included all subjects administered B-VEC or Placebo. Due to the 'split-person' intrasubject design, the safety assessments were reported at subject level, but not per intervention. | number of adverse events | NUMBER |
| PRIMARY | Complete Wound Closure Responder, ITT Population | from baseline at Weeks 8, 10, and 12 | The intent-to-treat (ITT) population: subjects who were administered KB103 who have had at least one paired assessment of the target wound area post-administration, i.e., at least one KB103 target wound and one placebo target wound.~The Safety population: all subjects who were administered IP. The per-protocol (PP) population: all subjects in the ITT population who have had at least one paired assessment of the target wound area post-administration and completed the protocol as planned. | number of responder | NUMBER |
| PRIMARY | Time to Wound Closure Analysis, ITT Population | baseline to complete wound closure | Intent to treat (ITT) included all subjects who were administered IP and had at least 1 post dose paired wound assessment. | days | MEDIAN |
| PRIMARY | Duration of Wound Closure, ITT Population | Time from the complete closure to the first reopening of the same wound | ITT population included all subjects who were administered IP and had at least 1 post dose paired wound assessment. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reported at Least One Adverse Event, Safety Population | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 9 | Participants | ||
| Number of Adverse Events Reported, Safety Population | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 35 | number of adverse events | ||
| Complete Wound Closure Responder, ITT Population | B-VEC | Week 8 | 14 | number of responder | |
| Complete Wound Closure Responder, ITT Population | Placebo | Week 8 | 0 | number of responder | |
| Complete Wound Closure Responder, ITT Population | B-VEC | Week 10 | 12 | number of responder | |
| Complete Wound Closure Responder, ITT Population | Placebo | Week 10 | 2 | number of responder | |
| Complete Wound Closure Responder, ITT Population | B-VEC | Week 12 | 12 | number of responder | |
| Complete Wound Closure Responder, ITT Population | Placebo | Week 12 | 1 | number of responder | |
| Time to Wound Closure Analysis, ITT Population | Topical Beremagene Geperpavec | 13.5 | 95% Confidence Interval 8.0 to 21.0 | days | |
| Time to Wound Closure Analysis, ITT Population | Placebo | 22.5 | 95% Confidence Interval 8.0 to 64.0 | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant 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) | 12 | 33 |
| Overall Study | B-VEC | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 12 | 21 |
| Overall Study | Placebo | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 12 | 12 |
| Overall Study | COMPLETED | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 11 | 31 |
| Overall Study | NOT COMPLETED | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 2 |
Source ClinicalTrials.gov
Adverse events28
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 | Application site pruritus | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 2 | 12 | 2 |
| other | Application site bruise | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
| other | Application site erythema | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
| other | Application site rash | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
| other | Fatigue | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
| other | Feeling cold | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
| other | Injection site erythema | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 2 |
| other | Injection site pain | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 3 |
| other | Injection site swelling | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
| other | Pyrexia | General disorders | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 1 | 12 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 | 12 |
| Total, other adverse events | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 9 | 12 |
| Total, serious adverse events | All Participants (Topical Beremagene Geperpavec (B-VEC), and Placebo) | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35347281 | RESULT |
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/NCT03536143
GET https://conductscience.org/api/trials/v1/NCT03536143/events?page=2