Trial · NCT02307513
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
NCT02307513, Phase 3, Completed, Amgen; results first posted 2019-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease. Trials, record NCT02307513. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02307513
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
- NCT number
- NCT02307513
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 207 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Behçet's Syndrome
- Interventions
- Apremilast, Placebo
- First posted
- 2014-12-04
- Last updated
- 2021-07-22
- Other registries' IDs
- eudract:2014-002108-25
- Results first posted
- 2019-09-11
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 (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) | Oral ulcers were assessed at weeks 0 (baseline), 1, 2, 4, 6, 8, 10, and 12 during the placebo-controlled period. | The number of oral ulcers that was counted for the analysis of the primary endpoint included current and recurrent ulcers at each time point; a single oral ulcer could be recounted multiple times if it persisted or recurred at subsequent visits. |
| Secondary | Change From Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale (VAS) at Week 12 | Baseline to week 12 | Pain of oral ulcers was measured using a 100 mm VAS scale. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was recorded. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12 | Baseline to week 12 | The Behçet's Syndrome Activity Score (BSAS) contains 10 questions that assess the number of new oral and genital ulcers and skin lesions, GI, CNS, vascular, and ocular involvement, and the participant's current level of discomfort. The Behçet's Syndrome Activity Score ranges from 0 to 100, with a higher score indicating a higher level of disease activity. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12 | Baseline to week 12 | The Behçet's Disease Current Activity Form (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 consists of 12 questions regarding disease manifestations over the previous 4 weeks, including oral and genital disease activity, as well as other manifestations of BD involving the skin, joints, GI tract, eyes, nervous system, and vascular system. The BDCAI score is the sum score of 12 items and ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening), and a negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12 | Baseline to week 12 | The Behçet's Disease Current Activity Form (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 Patient's Perception of Disease Activity was assessed on a scale from 1 to 7, where a higher score indicates a higher level of disease activity and a negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Clinician's Overall Perception of Disease Activity at Week 12 | Baseline to week 12 | The Behçet's Disease Current Activity Form (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 Clinician's Overall Perception of Disease Activity was assessed on a scale from 1 to 7, where a higher score indicates a higher level of disease activity and a negative change from baseline indicates improvement. |
| Secondary | Percentage of Participants Who Achieved an Oral Ulcer Complete Response (Oral Ulcer-Free) by Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks | Baseline to week 12 | Participants who were oral ulcer-free by week 6 and remained oral ulcer-free for at least 6 consecutive weeks during the 12-week placebo-controlled treatment phase. |
| Secondary | Time to Oral Ulcer Resolution (Complete Response) | Baseline to week 12 | Time to oral ulcer resolution (defined as oral ulcer-free) was the time between the first dose date and the date when a complete response was achieved for the first time during the placebo-controlled treatment phase. For participants who did not achieve complete response or discontinued treatment before a complete response was achieved during the placebo-controlled treatment phase, time to event was censored at the last oral ulcer assessment date during the placebo-controlled treatment phase or the first dose date if there were no postbaseline ulcer assessments. Median and 95% confidence interval was based on Kaplan-Meier estimates. |
| Secondary | Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12 | Week 12 | A complete response at week 12 was defined as participants who were oral ulcer free at week 12. |
| Secondary | Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12 | Baseline to week 12 | The Behçet's Disease Quality of Life questionnaire was developed to measure the influence of BD on a particpant's life. It consists of 30 self-completed itemized questions that measure disease-related restrictions on the participant's activities and their emotional response to these restrictions. The total score is the sum of all 30 items (each yes scores 1 and each no scores 0), with 0 representing no influence of Behçet's disease on a participant's quality of life and 30 representing the most severe influence. A negative change from baseline indicates improvement. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) | Oral ulcers were assessed at weeks 0 (baseline), 1, 2, 4, 6, 8, 10, and 12 during the placebo-controlled period. | The intent to treat (ITT) population included all randomized participants who received at least 1 dose of study drug. Multiple imputation (MI) was used to impute missing oral ulcer counts. | Ulcers*days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale (VAS) at Week 12 | Baseline to week 12 | The ITT population with available baseline data. Last observation carried forward (LOCF) imputation was used. LOCF is the last observation (baseline value if no post-baseline assessment) is carried forward for missing values at week 12. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12 | Baseline to week 12 | The intent to treat population with available baseline data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12 | Baseline to week 12 | The intent to treat population with available baseline data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12 | Baseline to week 12 | The intent to treat population with available data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Clinician's Overall Perception of Disease Activity at Week 12 | Baseline to week 12 | The intent to treat population with available baseline data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an Oral Ulcer Complete Response (Oral Ulcer-Free) by Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks | Baseline to week 12 | The intent to treat population | Percentage of participants | NUMBER |
| SECONDARY | Time to Oral Ulcer Resolution (Complete Response) | Baseline to week 12 | The intent to treat population | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12 | Week 12 | The intent to treat population; participants with missing data at week 12 were classified as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12 | Baseline to week 12 | The intent to treat population. LOCF was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) | Placebo | 222.14 | Standard Error 15.886 | Ulcers*days | |
| Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) | Apremilast 30 mg BID | 129.54 | Standard Error 15.943 | Ulcers*days | |
| Change From Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale (VAS) at Week 12 | Placebo | -15.9 | Standard Error 3.31 | mm | |
| Change From Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale (VAS) at Week 12 | Apremilast 30 mg BID | -40.7 | Standard Error 3.34 | mm | |
| Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12 | Placebo | -5.41 | Standard Error 1.776 | Units on a scale | |
| Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12 | Apremilast 30 mg BID | -17.35 | Standard Error 1.796 | Units on a scale | |
| Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12 | Placebo | -0.4 | Standard Error 0.20 | Units on a scale | |
| Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12 | Apremilast 30 mg BID | -0.9 | Standard Error 0.20 | Units on a scale | |
| Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12 | Placebo | -0.7 | Standard Error 0.18 | Units on a scale | |
| Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12 | Apremilast 30 mg BID | -1.7 | Standard Error 0.18 | Units on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo Controlled Phase (Weeks 0-12) | STARTED | Placebo/Apremilast | 103 | |
| Placebo Controlled Phase (Weeks 0-12) | STARTED | Apremilast | 104 | |
| Placebo Controlled Phase (Weeks 0-12) | COMPLETED | Placebo/Apremilast | 83 | |
| Placebo Controlled Phase (Weeks 0-12) | COMPLETED | Apremilast | 96 | |
| Placebo Controlled Phase (Weeks 0-12) | NOT COMPLETED | Placebo/Apremilast | 20 | |
| Placebo Controlled Phase (Weeks 0-12) | NOT COMPLETED | Apremilast | 8 | |
| Active Treatment Phase (Weeks 13-64) | STARTED | Placebo/Apremilast | 83 | |
| Active Treatment Phase (Weeks 13-64) | STARTED | Apremilast | 95 | |
| Active Treatment Phase (Weeks 13-64) | COMPLETED | Placebo/Apremilast | 68 | |
| Active Treatment Phase (Weeks 13-64) | COMPLETED | Apremilast | 75 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events184
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 |
|---|---|---|---|---|---|---|
| other | Dry eye | Eye disorders | Placebo-controlled Phase: Placebo | 1 | 103 | |
| other | Dry eye | Eye disorders | Placebo-controlled Phase: Apremilast 30 mg BID | 0 | 104 | |
| other | Dry eye | Eye disorders | Apremilast Exposure Period: Apremilast 30 mg BID | 0 | 187 | |
| other | Dry eye | Eye disorders | Open-label Extension Phase: Apremilast 30 mg BID | 1 | 2 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo-controlled Phase: Placebo | 3 | 103 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo-controlled Phase: Apremilast 30 mg BID | 4 | 104 | |
| other | Abdominal pain | Gastrointestinal disorders | Apremilast Exposure Period: Apremilast 30 mg BID | 12 | 187 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-label Extension Phase: Apremilast 30 mg BID | 0 | 2 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo-controlled Phase: Placebo | 2 | 103 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo-controlled Phase: Apremilast 30 mg BID | 9 | 104 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-controlled Phase: Placebo | 0 | 103 |
| Total, all-cause mortality | Placebo-controlled Phase: Apremilast 30 mg BID | 0 | 104 |
| Total, all-cause mortality | Apremilast Exposure Period: Apremilast 30 mg BID | 0 | 187 |
| Total, all-cause mortality | Open-label Extension Phase: Apremilast 30 mg BID | 0 | 2 |
| Total, other adverse events | Placebo-controlled Phase: Placebo | 52 | 103 |
| Total, other adverse events | Placebo-controlled Phase: Apremilast 30 mg BID | 67 | 104 |
| Total, other adverse events | Apremilast Exposure Period: Apremilast 30 mg BID | 132 | 187 |
| Total, other adverse events | Open-label Extension Phase: Apremilast 30 mg BID | 2 | 2 |
| Total, serious adverse events | Placebo-controlled Phase: Placebo | 4 | 103 |
| Total, serious adverse events | Placebo-controlled Phase: Apremilast 30 mg BID | 3 | 104 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
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GET https://conductscience.org/api/trials/v1/NCT02307513
GET https://conductscience.org/api/trials/v1/NCT02307513/results?page=2