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Apremilast 30 mg BID Combined With Dupilumab

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Apremilast
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and dated informed consent indicating the subject has been informed of all aspects of the study
  2. Subject is willing and able to comply with treatment plan, study drug administration, and study protocol requirements
  3. Subject has a documented clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to screening visit and is a candidate for systemic therapy
  4. Subjects must fulfill criteria outlined in the following clinical categories:

    • Subjects must be currently using and experiencing an inadequate response to dupilumab which is FDA approved for the treatment of moderate to severe atopic dermatitis. An inadequate response is defined as an IGA of 2 or more.
    • At the time of screening, subject must have a partial or inadequate response to their current treatment regimen. A partial or inadequate response at screening is defined as having both of the following:
    • Not having achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear).
    • Subjects must be on dupilumab for at least 12 weeks and willing to continue on dupilumab on a stable dose (40 mg weekly or every other week) while also receiving the study drug
  5. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options
  6. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on study medication and for at least 28 days after the last dose of study medication
  7. If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen. This includes emollients, which should stay stable throughout the study

Exclusion Criteria:

1. Prior hypersensitivity reaction or exposure to apremilast 2. Untreated or unstable depression or suicidality, including prior history of suicide attempt at any time in the subject's lifetime prior to Baseline Visit or major psychiatric illness requiring hospitalization within 3 years prior to Baseline Visit. Depression and suicidality will be assessed through standard-of-care questioning 3. Other than atopic dermatitis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled 4. Any condition, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 6. Pregnant or lactating females 7. Concomitant therapy with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin), which may cause loss of efficacy of apremilast.

8. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study.

9. Active substance abuse or a history of substance abuse within 6 months prior to Screening. Subjects will be asked about any history of substance use using standard of care questioning.

10. Malignancy or history of malignancy, except for:

  • treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas;
  • treated [i.e., cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.

    11. Use of dupilimab in combination with any other systemic immunosuppressant medication within 4 weeks prior to randomization or 5 pharmacokinetic/pharmacodynamic half lives, whichever is longer.

    12. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)

Sites / Locations

  • Tufts Medical Center, Department of DermatologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apremilast

Arm Description

Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability.

Outcomes

Primary Outcome Measures

Proportion of patients who achieve an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) from Baseline at Week 16.
Clinical improvement in a patient's eczematous lesions corresponds with a decrease in IGA, and a score of 0 (clear) or 1 (almost clear) is considered a significant clinical response.

Secondary Outcome Measures

Body Surface Area less than 3%
Percentage of subjects achieving BSA < 3% from Baseline at Week 16.
Body Surface Area Involvement
percentage change from baseline in percent of BSA involvement at Week 16.
Dermatology Life Quality Index (DLQI)
Percent change of the Dermatology Life Quality Index (DLQI) from baseline at Week 16.
Numerical Rating Scale (NRS)
Percentage change from baseline in itch on NRS pruritus scale at Week 16.
Eczema Area and Severity Index (EASI)
Percentage change from baseline in EASI score at Week 16.

Full Information

First Posted
March 4, 2020
Last Updated
July 1, 2022
Sponsor
Tufts Medical Center
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04306965
Brief Title
Apremilast 30 mg BID Combined With Dupilumab
Official Title
Apremilast 30 mg BID Combined With Dupilumab for the Treatment of Recalcitrant Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Open label phase 2 investigational study of efficacy and safety of apremilast 30 mg BID in chronic atopic dermatitis when added to the FDA approved treatment dupilumab for atopic dermatitis that is not providing adequate clinical responses.
Detailed Description
The purpose of this study is to determine if apremilast as a combined treatment for atopic dermatitis will provide increased efficacy outcomes in subjects who are currently using the FDA approved therapy of dupilumab but have responded only partially or inadequately to this therapy. Our hypothesis is that adding apremilast will allow patients to go from an inadequate response to dupilumab to an adequate response defined as an Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apremilast
Arm Type
Experimental
Arm Description
Apremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla
Intervention Description
30 mg BID
Primary Outcome Measure Information:
Title
Proportion of patients who achieve an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) from Baseline at Week 16.
Description
Clinical improvement in a patient's eczematous lesions corresponds with a decrease in IGA, and a score of 0 (clear) or 1 (almost clear) is considered a significant clinical response.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Body Surface Area less than 3%
Description
Percentage of subjects achieving BSA < 3% from Baseline at Week 16.
Time Frame
Baseline and Week 16
Title
Body Surface Area Involvement
Description
percentage change from baseline in percent of BSA involvement at Week 16.
Time Frame
Baseline and Week 16
Title
Dermatology Life Quality Index (DLQI)
Description
Percent change of the Dermatology Life Quality Index (DLQI) from baseline at Week 16.
Time Frame
Baseline and Week 16
Title
Numerical Rating Scale (NRS)
Description
Percentage change from baseline in itch on NRS pruritus scale at Week 16.
Time Frame
Baseline and Week 16
Title
Eczema Area and Severity Index (EASI)
Description
Percentage change from baseline in EASI score at Week 16.
Time Frame
Baseline and Week 16
Other Pre-specified Outcome Measures:
Title
Safety analysis
Description
Safety and tolerability will be evaluated by tabulations of adverse events
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent indicating the subject has been informed of all aspects of the study Subject is willing and able to comply with treatment plan, study drug administration, and study protocol requirements Subject has a documented clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to screening visit and is a candidate for systemic therapy Subjects must fulfill criteria outlined in the following clinical categories: Subjects must be currently using and experiencing an inadequate response to dupilumab which is FDA approved for the treatment of moderate to severe atopic dermatitis. An inadequate response is defined as an IGA of 2 or more. At the time of screening, subject must have a partial or inadequate response to their current treatment regimen. A partial or inadequate response at screening is defined as having both of the following: Not having achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear). Subjects must be on dupilumab for at least 12 weeks and willing to continue on dupilumab on a stable dose (40 mg weekly or every other week) while also receiving the study drug Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on study medication and for at least 28 days after the last dose of study medication If receiving concomitant medications for any reason, must be on a stable regimen and willing to stay on a stable regimen. This includes emollients, which should stay stable throughout the study Exclusion Criteria: 1. Prior hypersensitivity reaction or exposure to apremilast 2. Untreated or unstable depression or suicidality, including prior history of suicide attempt at any time in the subject's lifetime prior to Baseline Visit or major psychiatric illness requiring hospitalization within 3 years prior to Baseline Visit. Depression and suicidality will be assessed through standard-of-care questioning 3. Other than atopic dermatitis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled 4. Any condition, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 6. Pregnant or lactating females 7. Concomitant therapy with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin), which may cause loss of efficacy of apremilast. 8. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study. 9. Active substance abuse or a history of substance abuse within 6 months prior to Screening. Subjects will be asked about any history of substance use using standard of care questioning. 10. Malignancy or history of malignancy, except for: treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas; treated [i.e., cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years. 11. Use of dupilimab in combination with any other systemic immunosuppressant medication within 4 weeks prior to randomization or 5 pharmacokinetic/pharmacodynamic half lives, whichever is longer. 12. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole M Dumont
Phone
617 636 7462
Email
ndonovan1@tuftsmedicalcenter.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosmarin, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center, Department of Dermatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Dumont
Phone
617-636-7462
Email
ndonovan1@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
David Rosmarin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Apremilast 30 mg BID Combined With Dupilumab

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