Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

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Primary Purpose

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

dupilumab

About this trial

This is an expanded access trial for Bullous Pemphigoid focused on measuring Skin Diseases, Autoimmune Diseases, Immune System Diseases, Inflammatory Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Key Inclusion Criteria: 1. Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553) Key Exclusion Criteria: 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 Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit Treatment with BP-directed biologics, as defined in the protocol Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit Planned or anticipated use of any prohibited medications or procedures during program treatment 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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT05906706

First Posted

June 7, 2023

Last Updated

October 3, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT05906706

Brief Title

Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

Official Title

An Open-Label, Expanded Access Program of Dupilumab in Adult Patients With Bullous Pemphigoid

Study Type

Expanded Access

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

5. Study Description

Brief Summary

The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.

Detailed Description

Expanded Access requests are only being considered in response to intermediate size patient population applications. Availability will depend on location.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bullous Pemphigoid

Keywords

Skin Diseases, Autoimmune Diseases, Immune System Diseases, Inflammatory Diseases

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

dupilumab

Other Intervention Name(s)

REGN668, DUPIXENT®, SAR231893

Intervention Description

Subcutaneous (SC) administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Key Inclusion Criteria: 1. Completion of the end of study (EOS) visit in the parent dupilumab phase 2/3 study, R668-BP-1902 (NCT04206553) Key Exclusion Criteria: 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 Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit Treatment with BP-directed biologics, as defined in the protocol Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit Planned or anticipated use of any prohibited medications or procedures during program treatment 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Requests for compassionate use must be initiated by a treating physician. Physicians should contact:

Phone

844-734-6643

Email

CompassionateUse_Requests@regeneron.com

Bullous Pemphigoid

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial