A Pilot Multicentric Open Study Assessing the Efficacy and Safety of NEMOlizumab in Patients ≥ 12yo With Dystrophic Epidermolysis Bullosa
NCT07926867, Phase 2, Phase 3, Not yet recruiting, Centre Hospitalier Universitaire de Nice
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Pilot Multicentric Open Study Assessing the Efficacy and Safety of NEMOlizumab in Patients ≥ 12yo With Dystrophic Epidermolysis Bullosa | ClinicalTrials.gov |
| NCT number | NCT07926867 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre Hospitalier Universitaire de Nice | ClinicalTrials.gov |
| Conditions | Dystrophic Epidermolysis Bullosa | ClinicalTrials.gov |
| Interventions | Neolizumab | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To study the efficacy of Nemolizumab on pruritus in patients > 12yo with DEB after 4 weeks of treatment, in a multicentric, prospective, and open pilot study. | 4 weeks | The primary endpoint will be the proportion of patients achieving a clinically meaningful improvement in pruritus severity at Week 4 compared with baseline, defined as a reduction of at least 4 points on the Peak Pruritus Numerical Rating Scale (PP-NRS), which ranges from 0 (no itch) to 10 (worst itch imaginable). | ClinicalTrials.gov |
| Secondary | To describe the evolution of the following efficacy and health outcomes measures after 24 weeks of treatment | at 24 weeks | pain (scale 0-10) | ClinicalTrials.gov |
| Secondary | To describe the evolution of the following efficacy and health outcomes measures after 24 weeks of treatment | at baseline | pain (scale 0-10) | ClinicalTrials.gov |
| Secondary | To describe the evolution of the following efficacy and health outcomes measures after 24 weeks of treatment | at 24 weeks | quality of life (scale 0-30) | ClinicalTrials.gov |
| Secondary | To describe the evolution of the following efficacy and health outcomes measures after 24 weeks of treatment | at baseline | quality of life (scale 0-30) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)