Trial · NCT05334368
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
NCT05334368, Phase 3, Active not recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial. Trials, record NCT05334368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05334368
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
- NCT number
- NCT05334368
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypereosinophilic Syndrome
- Interventions
- Depemokimab, Placebo
- First posted
- 2022-04-19
- Last updated
- 2026-10-13
- Other registries' IDs
- eudract:2021-005692-39
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of HES flares | Up to 52 weeks | A HES flare is defined as either: a HES-related clinical manifestation based on a physician documented change in clinical signs or symptoms resulting in the need for the following : An increase in the maintenance systemic corticosteroid dose by at least 10 mg/day (prednisone/prednisolone equivalent) for at least 5 days, and/or an increase in or addition of any cytotoxic and/or immunosuppressive HES therapy. OR 2 or more courses of blinded active oral corticosteroid (OCS) during the intervention period. The frequency of HES flares will be calculated for each participant as the number of unique starting dates for HES flares. |
| Secondary | Time to first HES flare | Up to 52 weeks | The time to first HES flare will be calculated from the date of first dose of study intervention and the start date of the HES flare. Time to the first HES flare will be assessed and reported in days. |
| Secondary | Number of participants with at least one HES flare during the 52-week study intervention period | Up to 52 weeks | |
| Secondary | Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours) | Baseline and up to Week 52 | The BFI is a tool developed for the rapid assessment of fatigue severity for use in both clinical Screening and clinical trials. The BFI has 9 items. The participant should rate their average and worst fatigue levels over the previous 24 hours using a numeric rating scale anchored with 0 (no fatigue/interference) and 10 (as bad as you can imagine/completely interferes) numeric rating scales |
Source ClinicalTrials.gov
Outcomes0
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/NCT05334368
GET https://conductscience.org/api/trials/v1/NCT05334368/registered