Behçet DiseasePhase 3BEANNCT04528082
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
A Phase 3 study testing Apremilast in people with Behçet Disease, run by Amgen at 27 sites in 8 countries.
Trial summary
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Behçet Disease
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 9 Sep 2021to 17 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or Female participants 2 to < 18 years of age at randomization.
- Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.
- Oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit.
- Participant must have ≥ 2 oral ulcers at both the screening visit and on day 1.
- Participant has had prior treatment with ≥ 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.
Who cannot join
- Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), or CNS (eg, meningoencephalitis) manifestations, or ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:
- Previous major organ involvement is allowed if it occurred ≥1 year prior to the screening visit and is not active at time of enrollment
- Participants with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed
- Participants with BD-related arthritis and BD-skin manifestations are also allowed.
- Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).
Trial locations and contacts
27 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 8 countries
Spain6 sites, 5 recruiting
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
- Recruiting
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, 08950
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Terminated
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Turkey (Türkiye)6 sites, 5 recruiting
- Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
- Recruiting
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093
- Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
- Recruiting
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, 34764
- Terminated
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, 35330
- Recruiting
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, 38030
Italy4 sites, 2 recruiting
- Terminated
Ospedale Santissima Annunziata
Chieti, 66100
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
- Terminated
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
Milan, 20122
- Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165
France3 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon Hopital Femme Mere Enfant
Bron, 69677
- Terminated
Hopital Necker Enfants Malades
Paris, 75015
- Recruiting
Hopital Robert Debre
Paris, 75019
Greece3 sites, 3 recruiting
- Recruiting
Agia Sofia Children Hospital
Athens, 11527
- Recruiting
Attikon University General Hospital
Athens, 12462
- Recruiting
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, 54642
United Kingdom3 sites, 2 recruiting
- Terminated
Birmingham Childrens Hospital
Birmingham, B4 6NH
- Recruiting
Alder Hey Childrens Hospital
Liverpool, L12 2AP
- Recruiting
John Radcliffe Hospital
Oxford, OX3 7LD
Switzerland1 site
- Terminated
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
About this study
Official title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.
- Conditions
- Behçet Disease
- Being tested
- Apremilast, Placebo
- Keywords
- Behçet's Disease, Oral ulcers, Apremilast
- Medical subject headings
- Behcet Syndrome, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla®
Participants will receive apremilast orally.
PlaceboDrug
Participants will receive the matching placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | Participants will receive apremilast orally in the double-blind 12 week treatment phase. Then the participants will continue to receive apremilast in the active 40 weeks treatment phase. Receives: Drug: Apremilast |
| Placebo to Apremilast | Placebo comparator | Participants will receive the matching placebo orally in the double-blind 12 week treatment phase. Then the participants will receive apremilast in the active 40 weeks treatment phase. Receives: Drug: Apremilast; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12)
Measured: Week 0 to Week 12
Secondary outcomes (17)
Number of Oral Ulcers from Week 0 to Week 12
Measured: Week 0 to Week 12
Change from Week 0 to Week 12 in the Pain of Oral Ulcers in Participants 5 Years of Age and Older
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).
Measured: Week 0 to Week 12
Complete Response Rate for Oral Ulcers
Complete response rate for oral ulcers is defined as the proportion of participants who are oral ulcer free at Week 12.
Measured: Week 12
Proportion of Participants at Week 12 Whose Number of Oral Ulcers is Reduced by Greater Than or Equal to 50% from Week 0
Measured: Week 0 to Week 12
Complete Response Rate for Genital Ulcers
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.
Measured: Week 12
Change from Week 0 to Week 12 in Disease Activity
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.
Measured: Week 0 to Week 12
Proportion of Participants at Week 12 Who Have New-onset or Recurrence of Behçet's-related Manifestations (Other than Oral and Genital Ulcers)
Measured: Week 12
Change from Week 0 to Week 12 on the Short Form Survey (SF-10)
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.
Measured: Week 0 to Week 12
Number of Participants with a Treatment-emergent Adverse Event
Measured: Up to Week 56
Occurrence, Severity, and Frequency of Suicide/Suicide-related Ideations and Behaviors as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories:
Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Measured: Up to Week 56
Change from Week 0 to Week 52 in Tanner Staging
Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult.
Measured: Week 0 to Week 52
Change in Body Weight Measurements
Measured: Week 0 to Week 56
Change in Height Measurements
Measured: Week 0 to Week 56
Change in Body Mass Index (BMI)
BMI assessed as weight/(height/100)^2
Measured: Week 0 to Week 56
Plasma Concentrations of Apremilast
Measured: Up to Week 52
Taste and Acceptability of Apremilast
Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication.
Measured: Week 0 and Week 2
Proportion of Participants Who Require Protocol-prohibited Medications due to Worsening of Behçet's Disease
Measured: Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start9 Sep 2021
- Primary completion7 Feb 2030 (estimated)
- Study completion17 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomized to receive apremilast or placebo in the double-blind 12 week treatment phase. Then, the participants will all receive apremilast for a further 40 weeks in the active treatment phase. The participants will then complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase. Participants who complete the 52 weeks of treatment may have the opportunity to continue receiving apremilast through an open-label extension study (NCT05767047) . The participants who choose not to participate in the optional open-label, long-term study will complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528082
- Sponsor's protocol ID
- 20190530
- Other IDs
- 2023-503436-40-00, 2023
- Acronym
- BEAN
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
- ClinicalTrials.gov ID
- NCT04528082
- Acronym / sponsor ID
- BEAN / 20190530
- Conditions
- Behçet Disease
- Keywords
- Behçet's Disease, Oral ulcers, Apremilast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 7 Feb 2030 (estimated)
- Study completion
- 17 Dec 2030 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD) through week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomized to receive apremilast or placebo in the double-blind 12 week treatment phase. Then, the participants will all receive apremilast for a further 40 weeks in the active treatment phase. The participants will then complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase. Participants who complete the 52 weeks of treatment may have the opportunity to continue receiving apremilast through an open-label extension study (NCT05767047) . The participants who choose not to participate in the optional open-label, long-term study will complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastParticipants will receive apremilast orally in the double-blind 12 week treatment phase. Then the participants will continue to receive apremilast in the active 40 weeks treatment phase. |
| Placebo to Apremilast | Placebo comparator | Drug: Apremilast, Drug: PlaceboParticipants will receive the matching placebo orally in the double-blind 12 week treatment phase. Then the participants will receive apremilast in the active 40 weeks treatment phase. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or Female participants 2 to < 18 years of age at randomization.
- Diagnosed with BD meeting the ISGBD criteria at any time prior to the screening visit.
- Oral ulcers that occurred ≥ 3 times within the 12-month period prior to the screening visit.
- Participant must have ≥ 2 oral ulcers at both the screening visit and on day 1.
- Participant has had prior treatment with ≥ 1 non-biologic BD therapy, such as, but not limited to, topical corticosteroids or systemic treatment.
Key exclusion criteria (5 listed)
- Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), or CNS (eg, meningoencephalitis) manifestations, or ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:
- Previous exposure to biologic therapies for the treatment of BD oral ulcers, previous biologic exposure is allowed for other indications (including other manifestations of BD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: Otezla®Participants will receive apremilast orally. | Drug | Apremilast, Placebo to Apremilast |
| PlaceboParticipants will receive the matching placebo orally. | Drug | Placebo to Apremilast |
Primary outcome
Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12)
Time frame: Week 0 to Week 12
17 secondary outcomes
Number of Oral Ulcers from Week 0 to Week 12
Time frame: Week 0 to Week 12
Change from Week 0 to Week 12 in the Pain of Oral Ulcers in Participants 5 Years of Age and Older
Time frame: Week 0 to Week 12
Complete Response Rate for Oral Ulcers
Time frame: Week 12
Proportion of Participants at Week 12 Whose Number of Oral Ulcers is Reduced by Greater Than or Equal to 50% from Week 0
Time frame: Week 0 to Week 12
Complete Response Rate for Genital Ulcers
Time frame: Week 12
Change from Week 0 to Week 12 in Disease Activity
Time frame: Week 0 to Week 12
Proportion of Participants at Week 12 Who Have New-onset or Recurrence of Behçet's-related Manifestations (Other than Oral and Genital Ulcers)
Time frame: Week 12
Change from Week 0 to Week 12 on the Short Form Survey (SF-10)
Time frame: Week 0 to Week 12
Number of Participants with a Treatment-emergent Adverse Event
Time frame: Up to Week 56
Occurrence, Severity, and Frequency of Suicide/Suicide-related Ideations and Behaviors as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 56
Change from Week 0 to Week 52 in Tanner Staging
Time frame: Week 0 to Week 52
Change in Body Weight Measurements
Time frame: Week 0 to Week 56
Change in Height Measurements
Time frame: Week 0 to Week 56
Change in Body Mass Index (BMI)
Time frame: Week 0 to Week 56
Plasma Concentrations of Apremilast
Time frame: Up to Week 52
Taste and Acceptability of Apremilast
Time frame: Week 0 and Week 2
Proportion of Participants Who Require Protocol-prohibited Medications due to Worsening of Behçet's Disease
Time frame: Week 0 to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast in people with Behçet Disease, run by Amgen at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain, Turkey (Türkiye), Italy, France, Greece and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve for the Number of Oral Ulcers from Week 0 Through Week 12 (AUCw0-12) (time frame: Week 0 to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.