Behçet's DiseasePhase 3NCT05767047
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
A Phase 3 study testing Apremilast in people with Behçet's Disease and Juvenile Psoriatic Arthritis, run by Amgen at 7 sites in 4 countries.
Trial summary
The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Behçet's Disease, Juvenile Psoriatic Arthritis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 23 Mar 2023to 17 Mar 2036
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent / assent obtained
- Must have completed Week 52 on treatment on core study and must be < 18 years of age at the time the informed consent document is signed
- Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
- Willing to adhere to study visit schedule and protocol requirements
- Must have acceptable benefit/risk for continued treatment with apremilast
Who cannot join
- Answer "yes" to any question on C-SSRS at Week 52 visit of core study
- Scheduled surgery or other interventions that would interrupt study participation
- Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
- Female participants planning to become pregnant while on study through 30 days after last dose
- Female participants of childbearing potential with positive pregnancy test at Week 0
- Known sensitivity to any products to be administered during dosing
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
- Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098
- Recruiting
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, 34764
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Greece1 site, 1 recruiting
- Recruiting
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, 54642
About this study
Official title: A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
- Conditions
- Behçet's Disease, Juvenile Psoriatic Arthritis
- Being tested
- Apremilast
- Keywords
- Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla
- Medical subject headings
- Behcet Syndrome, Arthritis, Juvenile, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called AMG 407, Otezla, CC-10004
Oral tablets or liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | Participants with a weight between ≥ 12 kg to < 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to < 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Measured: Up to approximately 4 years
Columbia-Suicide Severity rating Scale (C-SSRS)
A questionnaire used to assess suicide risk.
Measured: Up to approximately 4 years
Tanner Staging
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Measured: Up to approximately 4 years
Change from Baseline in Body Weight
Measured: Up to approximately 4 years
Change from Baseline in Height
Measured: Up to approximately 4 years
Change from Baseline in Body Mass Index (BMI)
Measured: Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start23 Mar 2023
- Primary completion17 Mar 2036 (estimated)
- Study completion17 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT05767047
- Sponsor's protocol ID
- 20190531
- Other IDs
- 2022-003024-41, 2023-503433-21, 2023
- Status last verified
- Nov 2026
- First submitted
- 8 Mar 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05767047
- Acronym / sponsor ID
- 20190531
- Conditions
- Behçet's Disease, Juvenile Psoriatic Arthritis
- Keywords
- Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 17 Mar 2036 (estimated)
- Study completion
- 17 Mar 2036 (estimated)
- First posted
- 14 Mar 2023 (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 primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastParticipants with a weight between ≥ 12 kg to < 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to < 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Informed consent / assent obtained
- Must have completed Week 52 on treatment on core study and must be < 18 years of age at the time the informed consent document is signed
- Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
- Willing to adhere to study visit schedule and protocol requirements
- Must have acceptable benefit/risk for continued treatment with apremilast
Key exclusion criteria (6 listed)
- Answer "yes" to any question on C-SSRS at Week 52 visit of core study
- Scheduled surgery or other interventions that would interrupt study participation
- Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
- Female participants planning to become pregnant while on study through 30 days after last dose
- Female participants of childbearing potential with positive pregnancy test at Week 0
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: AMG 407, Otezla, CC-10004Oral tablets or liquid suspension | Drug | Apremilast |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to approximately 4 years
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Columbia-Suicide Severity rating Scale (C-SSRS)
Time frame: Up to approximately 4 years
A questionnaire used to assess suicide risk.
Tanner Staging
Time frame: Up to approximately 4 years
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Change from Baseline in Body Weight
Time frame: Up to approximately 4 years
Change from Baseline in Height
Time frame: Up to approximately 4 years
Change from Baseline in Body Mass Index (BMI)
Time frame: Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time frame: Up to approximately 4 years
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 4 Nov 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.
Related trials for Behçet's Disease
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Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
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Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
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Baricitinib in the Treatment of Intestinal Behçet's Syndrome
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Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
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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
7 sites in 4 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's Disease and Juvenile Psoriatic Arthritis, run by Amgen at 7 sites in 4 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 6 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye), Spain, Greece, Israel. 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. 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?
Number of Participants with Adverse Events (time frame: Up to approximately 4 years). The study lists 8 primary outcomes in all. 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 4 Nov 2026.