Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05906706




Registration number
NCT05906706
Ethics application status
Date submitted
7/06/2023
Date registered
18/06/2023
Date last updated
6/10/2023

Titles & IDs
Public title
Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid
Scientific title
An Open-Label, Expanded Access Program of Dupilumab in Adult Patients With Bullous Pemphigoid
Secondary ID [1] 0 0
R668-BP-2290-EAP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Key

1. Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553)

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who, during the parent dupilumab study, R668-BP-1902 (NCT04206553), developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to program drug and which led to discontinuation of investigational product
2. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit
3. Treatment with BP-directed biologics, as defined in the protocol
4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
5. Planned or anticipated use of any prohibited medications or procedures during program treatment
6. Severe concomitant illness(es) that, in the treating physician's judgment, would adversely affect the patient's participation in the program

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
AVAILABLE
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Requests for compassionate use must be initiated by a treating physician. Physicians should contact:
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05906706