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Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis (CLTofa23)

Primary Purpose

Cutaneous Leishmaniasis, American

Status
Not yet recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Oral tofacitinib
Parenteral meglumine antimoniate
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis, American focused on measuring Cutaneous Leishmaniasis, meglumine antimoniate, tofacitinib

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Corte de Pedra Health Post

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo and Sbv

Tofacitinib and Sbv

Arm Description

Eleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.

Eleven 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cure at 180 days
Absence of relapse after 180 days
Time to cure
Time (in days) until complete healing of the ulcer and re-epithelialization of the skin in the absence of infiltrated borders.
Adverse events
Adverse events will be recorded and graded

Full Information

First Posted
August 21, 2023
Last Updated
August 21, 2023
Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Instituto Gonçalo Muniz FIOCRUZ BA
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1. Study Identification

Unique Protocol Identification Number
NCT06011343
Brief Title
Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis
Acronym
CLTofa23
Official Title
Tofacitinib Associated With Meglumine Antimoniate in the Control of American Tegumentary Leishmaniasis. A Randomized and Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Instituto Gonçalo Muniz FIOCRUZ BA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
STUDY AREA The southeastern region of the State of Bahia, Brazil, where the village of Corte de Pedra and adjacent towns are located, is one of the most important American Tegumentary Leishmaniasis (ATL) endemic area in Latin America. The Corte de Pedra Health Center, in the municipality of Tancredo Neves, is located 280km from Salvador and is a Reference Center for Diagnosis and Treatment of ATL. Yearly, more than 500 cases of patients with ATL are diagnosed and treated at this Center. The Health Center was established in 1986 and clinical physicians, dermatologists, otorhinolaryngologists and immunologists from the Immunology Service of the Federal University of Bahia, the Gonçalo Moniz Institute (IGM) and the Federal University of Recôncavo Bahiano (UFRB) visit the area every two weeks. The Post also has the support of 4 trained health agents, all residents of the region. They assist patients, visit families, and participate in research activities. STUDY DESIGN A. Type of study: This project is a 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. the main objectives are: 1. To compare the cure rate of meglumine antimoniate associated with tofacitinib with meglumine antimoniate alone in the treatment of CL caused by L. braziliensis; 2. To determine whether combined treatment with meglumine antimoniate associated with tofacitinib reduces CL healing time. B. Definition of cases: Cutaneous Leishmaniasis: Presence of a typical ulcerated lesion on the skin, without evidence of mucosal involvement, with a positive skin test and disease duration between 30 and 90 days. The diagnosis will be made by identifying amastigotes in the histopathological study with immunohistochemistry and/or documentation of DNA for L.braziliensis by polymerase chain reaction (PCR). C. Methodology: The rate of cure or treatment failure is only defined on day 90 after starting therapy. We estimate that combining Glucantime with tofacitinib will increase the healing rate and reduce the healing time of CL. The present proposal is a proof of concept with the participation of patients with CL with disease duration between 30 and 90 days and with ulcer size between 10 and 60mm. Patients will be randomized, group 1 will receive Glucantime at a dose of 20mg/Kg/weight /day with a maximum dose of 1200mg intravenously for 20 days, and group 2 will be treated with Glucantime at the dose and time period described above associated with tofacitinib at a dose of 10mg/day for 30 days. Patients will be evaluated on day 0, day 30, day 60 and day 90 to determine the size and characteristics of the ulcers and the occurrence of wound healing. Sample size calculation: Considering that healing of ulcers up to 60mm in diameter in patients with CL with Glucantime will occur in 50% of patients while the cure rate in patients receiving Glucantime combined with tofacitinib will be 90% with a power of 80% and P< 0.05, 22 patients will be needed, 11 in each group. Subjects will be allocated in the 2 study arms after randomization at www.randomization.com. ETHICAL CONSIDERATIONS Participation in the study is voluntary and all participants must, after reading and understanding the nature of the study, benefits and risks, sign the attached Free and Informed Consent Form (TCLE). This study was approved by the ethics committee of the Faculty of Medicine of Bahia, Federal University of Bahia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis, American
Keywords
Cutaneous Leishmaniasis, meglumine antimoniate, tofacitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
CL patients will be allocated in 2 intervention groups.
Masking
ParticipantInvestigator
Masking Description
After randomization and allocation each patient will receive a code that will be confidential.
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo and Sbv
Arm Type
Placebo Comparator
Arm Description
Eleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
Arm Title
Tofacitinib and Sbv
Arm Type
Experimental
Arm Description
Eleven 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.
Intervention Type
Drug
Intervention Name(s)
Oral tofacitinib
Intervention Description
Association of tofacitinib and meglumine antimoniate
Intervention Type
Drug
Intervention Name(s)
Parenteral meglumine antimoniate
Intervention Description
Meglumine antimoniate
Primary Outcome Measure Information:
Title
Cure at 90 days
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Cure at 180 days
Description
Absence of relapse after 180 days
Time Frame
180 days
Title
Time to cure
Description
Time (in days) until complete healing of the ulcer and re-epithelialization of the skin in the absence of infiltrated borders.
Time Frame
Days
Title
Adverse events
Description
Adverse events will be recorded and graded
Time Frame
45 dyas

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EDGAR L CARVALHO, MD, PhD
Phone
7132377353
Email
imuno@ufba.br
First Name & Middle Initial & Last Name or Official Title & Degree
PAULO R LIMA MACHADO, MD, PhD
Phone
7132377353
Email
19pmachado@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EDGAR CARVALHO, MD, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corte de Pedra Health Post
City
Presidente Tancredo Neves
State/Province
Bahia
ZIP/Postal Code
40000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis

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