Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation
NCT07919899, Phase 3, Not yet recruiting, Sanofi
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation | ClinicalTrials.gov |
| NCT number | NCT07919899 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Conditions | Dermatitis Atopic | ClinicalTrials.gov |
| Interventions | Dupilumab coformulated with berahyaluronidase alfa, Dupilumab | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Ctrough,ss at Week 20 | Week 20 | Concentration observed before treatment administration during repeated dosing at steady state (SS). | ClinicalTrials.gov |
| Secondary | AUC0-4 weeks,ss | Week 0 through Week 4 | Area under curve from time point 0 to 28 days at steady state | ClinicalTrials.gov |
| Secondary | Cmax,ss | Week 20 | Maximum observed concentration during repeated dosing at steady state. | ClinicalTrials.gov |
| Secondary | Incidence of TEAEs, TE-AESIs, TE-SAEs, and TEAEs leading to permanent treatment discontinuation in the treatment-emergent period | Week 0 up to week 32 | TEAEs: treatment-emergent adverse events TE-AESIs: treatment-emergent adverse events of special interest TE-SAE: treatment-emergent serious adverse events | ClinicalTrials.gov |
| Secondary | Incidence of potentially clinically significant abnormalities in laboratory test, vital signs, and ECGs abnormalities in the treatment-emergent period | Week 0 up to week 32 | ClinicalTrials.gov | |
| Secondary | Incidence of treatment-emergent anti-drug antibody (ADA) to dupilumab through Week 20 | Week 0 up to week 20 | ClinicalTrials.gov | |
| Secondary | Incidence of treatment-emergent ADA to ALT-B4 through Week 20 | Week 0 up to week 20 | 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)