NL-OMON40034
Completed
Phase 2
A first-in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome (CBPR277X2101) - CBPR277X2101
ovartis Pharma BV0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Netherton syndrome
- Sponsor
- ovartis Pharma BV
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients with Netherton syndrome, 18 to 65 years of age inclusive.
- •Confirmed diagnosis of Netherton syndrome (SPINK5 mutation and/or LEKTI deficiency in the skin).
- •Total lesional sign score NS (TLSS\-NS) of 5\-9 for each selected treatment area at baseline.
- •Each treatment area must have a minimum of approximately 250 cm2 of lesional skin within a maximum of approximately 1500 cm2\. The TLSS\-NS values of both treatment areas need to be similar and, if possible, should not differ (±) by more than 1 point between the two areas at baseline.
Exclusion Criteria
- •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 not using acceptable contraceptive methods.
- •Recent previous treatment with phototherapy, biological therapy, immunosuppressive agents (see protocol page 62 for details).
Outcomes
Primary Outcomes
Not specified
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