A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome (3)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01428297
First received: August 19, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Healthy Volunteers
Atopic Dermatitis
Netherton Syndrome
Drug: BPR277 ointment (controlled application)
Drug: Placebo (Vehicle)
Drug: BPR277 ointment
Drug: BPR277
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
  • Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A and B, BPR277 and Placebo (vehicle) Drug: BPR277 ointment (controlled application) Drug: Placebo (Vehicle)
Experimental: Part 2 BPR277 Drug: BPR277 ointment
Placebo Comparator: Part 2 Placebo (vehicle) Drug: Placebo (Vehicle)
Experimental: Part 3 BPR277 and Placebo (vehicle) Drug: BPR277 Drug: Placebo (Vehicle)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428297

Locations
United States, Connecticut
Novartis Investigative Site
New Haven, Connecticut, United States, 06519
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63104
United States, North Dakota
Novartis Investigative Site
Fargo, North Dakota, United States, 58104
Netherlands
Novartis Investigative Site
Utrecht, the Netherlands, Netherlands, 3508 GA
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01428297     History of Changes
Other Study ID Numbers: CBPR277X2101, 2011-000917-38
Study First Received: August 19, 2011
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Atopic dermatitis
Eczema
Skin Diseases, Eczematous
Netherton syndrome
Skin Diseases, Genetic
BPR277

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Netherton Syndrome
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Ichthyosiform Erythroderma, Congenital
Ichthyosis
Skin Abnormalities
Infant, Newborn, Diseases
Keratosis

ClinicalTrials.gov processed this record on August 26, 2014