Trial · NCT04528082
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
NCT04528082, Phase 3, Recruiting, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease. Trials, record NCT04528082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04528082
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
- NCT number
- NCT04528082
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Amgen
- Conditions
- Behçet Disease
- Interventions
- Apremilast, Placebo
- First posted
- 2020-08-27
- Last updated
- 2026-07-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12) | Week 0 to Week 12 | |
| Secondary | Number of Oral Ulcers from Week 0 to Week 12 | Week 0 to Week 12 | |
| Secondary | Change from Week 0 to Week 12 in the Pain of Oral Ulcers in Participants 5 Years of Age and Older | Week 0 to Week 12 | Pain of oral ulcers will be measured by a visual analog scale (VAS). The participants will be asked to place a vertical line on a 100 mm VAS at the point that represents the severity of oral ulcer pain. The scale will range from "no pain" (left hand boundary) to "worst possible pain" (right hand boundary). |
| Secondary | Complete Response Rate for Oral Ulcers | Week 12 | Complete response rate for oral ulcers is defined as the proportion of participants who are oral ulcer free at Week 12. |
| Secondary | Proportion of Participants at Week 12 Whose Number of Oral Ulcers is Reduced by Greater Than or Equal to 50% from Week 0 | Week 0 to Week 12 | |
| Secondary | Complete Response Rate for Genital Ulcers | Week 12 | Complete response rate for genital ulcers is defined as the proportion of participants (with genital ulcers at week 0) who are genital ulcer free at Week 12. |
| Secondary | Change from Week 0 to Week 12 in Disease Activity | Week 0 to Week 12 | Disease activity is measured by Behçet's Disease Current Activity (BDCAF) scores. The BDCAF consists of 3 component scores: the Behçet's Disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity. The BDCAI score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening), and a negative change from baseline indicates improvement. The Patient's Perception of Disease Activity and the Clinician's Overall Perception of Disease Activity were assessed by the subject and the clinician, respectively, using a scale of 1 to 7, where a higher score indicates a higher level of disease activity. |
| Secondary | Proportion of Participants at Week 12 Who Have New-onset or Recurrence of Behçet's-related Manifestations (Other than Oral and Genital Ulcers) | Week 12 | |
| Secondary | Change from Week 0 to Week 12 on the Short Form Survey (SF-10) | Week 0 to Week 12 | The SF-10 Health Survey for Children is a parent-completed survey that contains 10 questions adapted from the Child Health Questionnaire. The SF-10 is intended to produce physical and psychosocial health summary measures. Each of the 10 questions responses is scored with a point value from 1 to 6 (1 is the worst possible condition and 6 is the best possible condition). The SF-10 physical and psychosocial measures are scored such that higher scores indicate more favorable functioning. |
| Secondary | Number of Participants with a Treatment-emergent Adverse Event | Up to Week 56 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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/NCT04528082
GET https://conductscience.org/api/trials/v1/NCT04528082/registered