A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

NCT ID: NCT01428297

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-02-28

Brief Summary

The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).

Conditions

Healthy Volunteers; Atopic Dermatitis; Netherton Syndrome

Keywords

Atopic dermatitis; Eczema; Skin Diseases, Eczematous; Netherton syndrome; Skin Diseases, Genetic; BPR277

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A and B, BPR277 and Placebo (vehicle)

Group Type: EXPERIMENTAL

BPR277 ointment (controlled application)

Intervention Type: DRUG

Placebo (Vehicle)

Intervention Type: DRUG

Part 2 BPR277

Group Type: EXPERIMENTAL

BPR277 ointment

Intervention Type: DRUG

Part 2 Placebo (vehicle)

Group Type: PLACEBO_COMPARATOR

Placebo (Vehicle)

Intervention Type: DRUG

Part 3 BPR277 and Placebo (vehicle)

Group Type: EXPERIMENTAL

BPR277

Intervention Type: DRUG

Placebo (Vehicle)

Intervention Type: DRUG

Interventions

BPR277 ointment (controlled application)

Intervention Type: DRUG

Placebo (Vehicle)

Intervention Type: DRUG

BPR277 ointment

Intervention Type: DRUG

Placebo (Vehicle)

Intervention Type: DRUG

BPR277

Intervention Type: DRUG

Placebo (Vehicle)

Intervention Type: DRUG

Eligibility Criteria

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 examinations
• Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:

1. History of involvement of the skin creases

2. Personal history of asthma or hay fever

3. History of generally dry skin in the past year

4. Onset before age of 2 years

5. Visible flexural dermatitis

• Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)

Part 3 Patients with Netherton Syndrome:

• Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
• Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin).
• Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline.

Exclusion Criteria

Part 1 Healthy volunteers :

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
• Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.

Part 2 Patients with atopic dermatitis:

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
• History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
• Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
• Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.

Part 3 Patients with Netherton Syndrome:

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
• History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
• Use of topical prescription treatment within 2 week prior to initial dosing of study drug.
• Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

New Haven, Connecticut, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Fargo, North Dakota, United States

Novartis Investigative Site

Utrecht, The Netherlands, Netherlands

Countries

France; Germany; United States; Netherlands

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13551

Results for CBPR277X2101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

2011-000917-38

Identifier Type: -

Identifier Source: secondary_id

CBPR277X2101

Identifier Type: -

Identifier Source: org_study_id