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BPR277

Phase 1

Atopic Dermatitis | Small molecule | Rare Disease |Novartis AG|Trials Updated: Dec 8, 2020

BPR277 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2011

BPR277 target and mechanism

ModalitySmall molecule

Also known as BPR277 ointment (controlled application)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

BPR277 clinical trials

BPR277 · 1 trial · 3 indications

Phase 1 1
NCT01428297A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton SyndromeHealthy Volunteers
COMPLETED12 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
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Study Endpoints

Primary Endpoints

Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry.
2-4 weeks
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area
4 weeks

Secondary Endpoints

Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change for each sign comprising the total lesional signs score at the treated skin area
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A and B, BPR277 and Placebo (vehicle)EXPERIMENTAL -
Part 2 BPR277EXPERIMENTAL -
Part 2 Placebo (vehicle)PLACEBO_COMPARATOR -
Part 3 BPR277 and Placebo (vehicle)EXPERIMENTAL -

Interventions

NameTypeDescription
BPR277 ointment (controlled application)DRUG -
Placebo (Vehicle)DRUG -
BPR277 ointmentDRUG -
BPR277DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: Part 1 Healthy volunteers * Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health Part 2 Patients with atopic dermatitis: * Male and female subjects, 18 to 65 years of age inclusive and having passed screening exami...

Countries:United StatesNetherlands
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Frequently asked questions about BPR277

What is BPR277?

BPR277 is an investigational small molecule developed by Novartis AG for topical treatment of atopic dermatitis. It is also known as BPR277 ointment (controlled application). The compound has been studied in a Phase 1 clinical trial that also included Netherton syndrome and healthy volunteers. BPR277 is not approved and remains in clinical development.

What is BPR277 used for in atopic dermatitis?

BPR277 is being studied for the topical treatment of atopic dermatitis, a chronic inflammatory skin condition. The Phase 1 trial of BPR277 also enrolled participants with Netherton syndrome and healthy volunteers. Because the program is at Phase 1, BPR277 has not been established as a treatment for atopic dermatitis and is not approved for any use.

Who makes BPR277?

BPR277 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 study of topical BPR277 in atopic dermatitis, Netherton syndrome, and healthy volunteers. No other developer is associated with the asset in the available program information.

What phase is BPR277 in?

BPR277 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The study was randomized, double-blind, and placebo-controlled, enrolling 12 participants. BPR277 is investigational and has not been approved by the FDA or any other regulator.

What clinical trials is BPR277 in?

BPR277 has been evaluated in one completed Phase 1 trial, NCT01428297, titled A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome. The trial enrolled 12 participants across the United States and the Netherlands, included healthy volunteers, and used a randomized, double-blind, placebo-controlled design.

Is BPR277 the same as BPR277 ointment (controlled application)?

Yes. BPR277 ointment (controlled application) is another name for BPR277, the topical small molecule developed by Novartis AG. Both names refer to the same investigational compound studied in the completed Phase 1 trial NCT01428297 for atopic dermatitis, Netherton syndrome, and healthy volunteers.