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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03780166 |
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Date of registration:
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17/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
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Scientific title:
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A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris |
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Date of first enrolment:
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March 2019 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03780166 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Contacts
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Name:
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Kathleen Butler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Incyte Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6
months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3;
Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal
lesions.
- Disease progression after treatment with standard therapies that are known to confer
clinical benefit, or intolerant to treatment; there is no limit to the number of prior
treatment regimens.
- Willingness to avoid pregnancy or fathering children.
- If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during
the study period.
Exclusion Criteria:
- Pregnant or breast-feeding female.
- Participants with pemphigus vulgaris who are treatment-naive.
- Use of protocol-specified medications within defined periods before baseline.
- Evidence or history of clinically significant infection or protocol-defined medical
conditions
- Laboratory values outside the protocol-defined range at screening.
- Known or suspected allergy to parsaclisib or any component of the study drug.
- Known history of clinically significant drug or alcohol abuse in the last year before
baseline.
- Inability or unlikeliness of the participant to comply with the dose schedule and
study evaluations, in the opinion of the investigator.
- Any condition that would, in the investigator's judgment, interfere with full
participation in the study, including administration of study drug and attending
required study visits; pose a significant risk to the participant; or interfere with
interpretation of study data.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pemphigus Vulgaris
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Intervention(s)
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Drug: Parsaclisib
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Primary Outcome(s)
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Number of treatment-emergent adverse events
[Time Frame: Up to 20 weeks]
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Secondary Outcome(s)
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AUC0-t of Parsaclisib
[Time Frame: Up to 6 weeks]
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Cmax of Parsaclisib
[Time Frame: Up to 6 weeks]
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CL/F of Parsaclisib
[Time Frame: Up to 6 weeks]
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Cmin of Parsaclisib
[Time Frame: Up to 6 weeks]
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tmax of Parsaclisib
[Time Frame: Up to 6 weeks]
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Secondary ID(s)
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INCB 50465-208
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Parsaclisib
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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