Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis
CLTofa23
1 other identifier
interventional
22
1 country
1
Brief Summary
Phase 2/3 randomized and controlled clinical trial, which will evaluate the effectiveness of the association meglumine antimoniate (Glucantime) with tofacitinib in the cure of CL and the capacity of this association to reduce the time of cure of the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2023
1 active site
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
First Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedAugust 25, 2023
August 1, 2023
1 year
August 21, 2023
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure at 90 days
Healing will be defined by complete healing of the ulcer and re-epithelialization of the skin on day 90, in the absence of infiltrated borders. Failure will be defined as persistence of the ulcer at day 90 with ulcer healing occurring but persistent infiltration at the edges.
90 days
Secondary Outcomes (3)
Cure at 180 days
180 days
Time to cure
Days
Adverse events
45 dyas
Study Arms (2)
Placebo and Sbv
PLACEBO COMPARATOREleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
Tofacitinib and Sbv
EXPERIMENTALEleven CL patients will receive oral tofatinib (10mg daily for 30 days) associated to meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with CL of both sexes with disease duration between 30 and 90 days. Patients with CL will be treatment-naïve for leishmaniasis. Individuals will be explained about the nature of the study and will only be included if they agree to participate and sign the Free and Informed Consent Form.
You may not qualify if:
- Patients under the age of 18 and pregnant women will not participate in the study considering the need to withdraw 30 ml of blood to carry out the studies of the immune response. Patients over 60 years old, debilitating chronic diseases such as heart failure, liver failure, kidney failure, HIV infection and use of immunosuppressant drugs will also not participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corte de Pedra Health Post
Presidente Tancredo Neves, Estado de Bahia, 40000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EDGAR CARVALHO, MD, PhD
Federal University of Bahia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- After randomization and allocation each patient will receive a code that will be confidential.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
August 21, 2023
First Posted
August 25, 2023
Study Start
October 1, 2023
Primary Completion
October 1, 2024
Study Completion
July 1, 2025
Last Updated
August 25, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to make IPD available.