NCT01428297

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2011

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

December 8, 2020

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

August 19, 2011

Last Update Submit

December 6, 2020

Conditions

Healthy VolunteersAtopic DermatitisNetherton Syndrome

Keywords

Atopic dermatitisEczemaSkin Diseases, EczematousNetherton syndromeSkin Diseases, GeneticBPR277

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (4)

Cohort A and B, BPR277 and Placebo (vehicle)

EXPERIMENTAL
Drug: BPR277 ointment (controlled application)Drug: Placebo (Vehicle)

Part 2 BPR277

EXPERIMENTAL
Drug: BPR277 ointment

Part 2 Placebo (vehicle)

PLACEBO COMPARATOR
Drug: Placebo (Vehicle)

Part 3 BPR277 and Placebo (vehicle)

EXPERIMENTAL
Drug: BPR277Drug: Placebo (Vehicle)

Interventions

BPR277 ointment (controlled application)DRUG
Cohort A and B, BPR277 and Placebo (vehicle)
Placebo (Vehicle)DRUG
Cohort A and B, BPR277 and Placebo (vehicle)
BPR277 ointmentDRUG
Part 2 BPR277
BPR277DRUG
Part 3 BPR277 and Placebo (vehicle)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • History of involvement of the skin creases
  • Personal history of asthma or hay fever
  • History of generally dry skin in the past year
  • Onset before age of 2 years
  • 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.

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

New Haven, Connecticut, 06519, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63104, United States

Location

Novartis Investigative Site

Fargo, North Dakota, 58104, United States

Location

Novartis Investigative Site

Utrecht, The Netherlands, 3508 GA, Netherlands

Location

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicNetherton SyndromeEczemaSkin Diseases, EczematousSkin Diseases, Genetic

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesAbnormalities, MultipleCongenital AbnormalitiesIchthyosiform Erythroderma, CongenitalIchthyosisSkin AbnormalitiesInfant, Newborn, DiseasesKeratosis

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2011

First Posted

September 2, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

December 8, 2020

Record last verified: 2015-02

Locations

US(3)NL(1)