Bechet's DiseaseNCT03740516
Expanded Access for CC-10004
A study testing CC-10004 in people with Bechet's Disease, run by Amgen at 1 site in United States.
Trial summary
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-10004. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bechet's Disease
- What is being tested?
- CC-10004
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-10004.
- Conditions
- Bechet's Disease
- Being tested
- CC-10004
- Keywords
- Expanded Access, Compassionate Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-10004Drug
Also called Apremilast, Otezla
CC-10004 will be administered orally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bechet'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
- Expanded access
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
- NCT03740516
- Sponsor's protocol ID
- CC-10004
- Status last verified
- Apr 2020
- First submitted
- 31 Oct 2018
- Last updated
- 29 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for CC-10004
- ClinicalTrials.gov ID
- NCT03740516
- Acronym / sponsor ID
- CC-10004
- Conditions
- Bechet's Disease
- Keywords
- Expanded Access, Compassionate Use
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 14 Nov 2018 (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.
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-10004.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CC-10004Also: Apremilast, OtezlaCC-10004 will be administered orally | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
Related trials for Bechet's Disease
Not yet recruitingPhase 2
A Long-term Study of HSK44459 Tablets in Participants With Bechet's Disease
Bechet's Disease
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. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC-10004 in people with Bechet's Disease, run by Amgen at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 29 Apr 2020.