Brimonidine Tartrate for the Treatment of Injection Related Erythema (BRITE)

Biogen

Status and phase: Withdrawn; Phase 4

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Treatments: Drug: brimonidine tartrate; Drug: peginterferon beta-1a; Drug: Vehicle Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02568111

2015-002159-89 (EudraCT Number)

NLD-PEG-14-10784

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups, including a placebo group

brimonidine tartrate

Experimental group

Description:

Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection

Treatment:

Drug: peginterferon beta-1a

Drug: brimonidine tartrate

Vehicle Gel

Placebo Comparator group

Description:

Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection

Treatment:

Drug: peginterferon beta-1a

Drug: Vehicle Gel