Pemphigus VulgarisPhase 2NCT03780166
A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris
A Phase 2 study testing Parsaclisib in people with Pemphigus Vulgaris, run by Incyte Corporation.
Trial summary
The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pemphigus Vulgaris
- What is being tested?
- Parsaclisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.
- Conditions
- Pemphigus Vulgaris
- Being tested
- Parsaclisib
- Keywords
- Pemphigus vulgaris, phosphatidylinositol 3-kinase delta, immunoglobulin G autoantibodies
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called INCB050465
Parsaclisib administered orally once daily at the cohort-specified dose level.
| Study group | Role | What they receive |
|---|---|---|
| Parsaclisib | Experimental | Not described Receives: Drug: Parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to 20 weeks
Secondary outcomes (5)
Cmax of Parsaclisib
Maximum observed concentration.
Measured: Up to 6 weeks
tmax of Parsaclisib
Time to maximum concentration.
Measured: Up to 6 weeks
Cmin of Parsaclisib
Minimum observed concentration over the dose interval.
Measured: Up to 6 weeks
AUC0-t of Parsaclisib
Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measured: Up to 6 weeks
CL/F of Parsaclisib
Apparent oral dose clearance.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startMar 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Why it stopped: The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Butler, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780166
- Sponsor's protocol ID
- INCB 50465-208
- Other IDs
- Parsaclisib
- Status last verified
- Sep 2019
- First submitted
- 17 Dec 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
- ClinicalTrials.gov ID
- NCT03780166
- Acronym / sponsor ID
- INCB 50465-208
- Conditions
- Pemphigus Vulgaris
- Keywords
- Pemphigus vulgaris, phosphatidylinositol 3-kinase delta, immunoglobulin G autoantibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to insufficient interest in study participation due to recent approval in this rare condition.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parsaclisib | Experimental | Drug: Parsaclisib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParsaclisibAlso: INCB050465Parsaclisib administered orally once daily at the cohort-specified dose level. | Drug | Parsaclisib |
Primary outcome
Number of treatment-emergent adverse events
Time frame: Up to 20 weeks
Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
5 secondary outcomes
Cmax of Parsaclisib
Time frame: Up to 6 weeks
tmax of Parsaclisib
Time frame: Up to 6 weeks
Cmin of Parsaclisib
Time frame: Up to 6 weeks
AUC0-t of Parsaclisib
Time frame: Up to 6 weeks
CL/F of Parsaclisib
Time frame: Up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Butler, MD study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parsaclisib in people with Pemphigus Vulgaris, run by Incyte Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events (time frame: Up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.