Trial · NCT07893483
Safety, Tolerability, and Efficacy of Oral KM-023 in Adult Patients With Pachyonychia Congenita (pEDD-PC)
NCT07893483, Phase 2, Not yet recruiting, Orvida Pharma (formerly Kamari Pharma)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, and Efficacy of Oral KM-023 in Adult Patients With Pachyonychia Congenita (pEDD-PC). Trials, record NCT07893483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Oral KM-023 in Adult Patients With Pachyonychia Congenita (pEDD-PC)
- NCT number
- NCT07893483
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Orvida Pharma (formerly Kamari Pharma)
- Conditions
- Pachyonychia Congenita
- Interventions
- KM-023
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the safety of repeated doses of oral KM-023 in individuals with PC. | Day 112 | The incidence, seriousness, relationship, and outcome of TEAEs. |
| Primary | To assess the safety of repeated doses of oral KM-023 in individuals with PC. | Day 112 | Change from baseline in clinical laboratory parameters. |
| Primary | To assess the safety of repeated doses of oral KM-023 in individuals with PC. | Day 112 | Change from baseline in vital signs. |
| Primary | To assess the safety of repeated doses of oral KM-023 in individuals with PC. | Day 112 | Change from baseline in 12-lead ECG |
| Primary | To assess the safety of repeated doses of oral KM-023 in individuals with PC. | Day 112 | Change from baseline in physical examination. |
| Primary | To assess the tolerability of repeated doses of oral KM-023 in individuals with PC. | Day 112 | Proportions of participants who completed 112 days of treatment and who discontinued treatment due to a TEAE (tolerability). |
| Secondary | Change from baseline to Day 112 in duration of the Timed up and Go (TUG) test completion. | Day 112 | |
| Secondary | Change from baseline to Day 112 in post-TUG test pain NRS score. | Day 112 | |
| Secondary | Change from baseline to Day 112 in pre-TUG test pain numeric rating scale (NRS) score. | Day 112 | |
| Secondary | Change from baseline to Day 112 in the weekly average of three times a week plantar pain NRS assessment. | Day 112 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT07893483
GET https://conductscience.org/api/trials/v1/NCT07893483/registered