Brimonidine Tartrate for the Treatment of Injection Related Erythema

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo). The secondary study objectives are to evaluate the IRE mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent definition scale, in accordance with the primary endpoint of the original brimonidine pivotal trials and participants' satisfaction with the overall appearance of their skin.

Detailed Description
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Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study.

Official Title
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Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)

Conditions
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Relapsing-Remitting Multiple Sclerosis (RRMS)

Intervention / Treatment
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* Drug: peginterferon beta-1a
* Drug: brimonidine tartrate
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician. Patient willing and able to complete PSA and PAA questionnaires with minimal assistance. Key Exclusion Criteria: Known allergy to any interferon or any component of peginterferon beta-1a. Patients with hypersensitivity to Brimonidine topical gel. Patients with other skin disorders. History of previous treatment with Brimonidine tartrate. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brimonidine tartrate<br>Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection | Drug: peginterferon beta-1a<br>* SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29<br>* Other names: BIIB017;Drug: brimonidine tartrate<br>* Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.<br>* Other names: Mirvaso;|
| Placebo Comparator: Vehicle Gel<br>Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection | Drug: peginterferon beta-1a<br>* SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29<br>* Other names: BIIB017;Drug: Vehicle Gel<br>* Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (PSA) scale measured as at least 1-grade improvement on CEA and/or at least 1-grade improvement on PSA scale assessed by the physician and participant | Investigator will evaluate participant's erythema (redness) at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema. Participants rate erythema at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema. | Before and after 6 hours of gel application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively | This composite endpoint is considered to be sensitive enough and directly correlated with participants' satisfaction therapy outcomes. | Before and after 6 hours of gel application | 
| Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA |  | Before and after 6 hours of gel application | 
| Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale | PAA satisfaction score will describe how satisfied the participants are with the overall appearance of skin on a scale of 0 (very satisfied) to 4 (very dissatisfied). | Before and after 6 hours of gel application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erythema, PLEGRIDY, injection site reaction (ISR), MS, RRMS