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

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ClinicalTrials.gov Identifier: NCT01428297
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : February 4, 2015
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE August 19, 2011
First Posted Date  ICMJE September 2, 2011
Last Update Posted Date February 4, 2015
Study Start Date  ICMJE May 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01428297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy Volunteers
  • Atopic Dermatitis
  • Netherton Syndrome
Intervention  ICMJE
  • Drug: BPR277 ointment (controlled application)
  • Drug: Placebo (Vehicle)
  • Drug: BPR277 ointment
  • Drug: BPR277
Study Arms  ICMJE
  • Experimental: Cohort A and B, BPR277 and Placebo (vehicle)
    Interventions:
    • Drug: BPR277 ointment (controlled application)
    • Drug: Placebo (Vehicle)
  • Experimental: Part 2 BPR277
    Intervention: Drug: BPR277 ointment
  • Placebo Comparator: Part 2 Placebo (vehicle)
    Intervention: Drug: Placebo (Vehicle)
  • Experimental: Part 3 BPR277 and Placebo (vehicle)
    Interventions:
    • Drug: BPR277
    • Drug: Placebo (Vehicle)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2011)
65
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   United States
Removed Location Countries France,   Germany
 
Administrative Information
NCT Number  ICMJE NCT01428297
Other Study ID Numbers  ICMJE CBPR277X2101
2011-000917-38
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Disclosure Office, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP