Cutaneous Leishmaniasis, AmericanPhase 2/3CLTofa23NCT06011343
Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis
A Phase 2/3 study testing Oral tofacitinib and Parenteral meglumine antimoniate in people with Cutaneous Leishmaniasis, American, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cutaneous Leishmaniasis, American
- What is being tested?
- Oral tofacitinib and Parenteral meglumine antimoniate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2023to 1 Jul 2025
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Corte de Pedra Health Post
Presidente Tancredo Neves, Estado de Bahia, 40000
About this study
Official title: Tofacitinib Associated With Meglumine Antimoniate in the Control of American Tegumentary Leishmaniasis. A Randomized and Controlled Clinical Trial.
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.
Read the 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
- 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.
- 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).
- 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.
- Conditions
- Cutaneous Leishmaniasis, American
- Being tested
- Oral tofacitinib, Parenteral meglumine antimoniate
- Keywords
- Cutaneous Leishmaniasis, meglumine antimoniate, tofacitinib
- Medical subject headings
- Leishmaniasis, Mucocutaneous, Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tofacitinibDrug
Association of tofacitinib and meglumine antimoniate
Parenteral meglumine antimoniateDrug
Meglumine antimoniate
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Sbv | Placebo comparator | Eleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days. Receives: Drug: Parenteral meglumine antimoniate |
| Tofacitinib and Sbv | Experimental | 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. Receives: Drug: Oral tofacitinib; Drug: Parenteral meglumine antimoniate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (3)
Cure at 180 days
Absence of relapse after 180 days
Measured: 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.
Measured: Days
Adverse events
Adverse events will be recorded and graded
Measured: 45 dyas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Leishmaniasis, AmericanStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CL patients will be allocated in 2 intervention groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Gonçalo Muniz FIOCRUZ BA
- Responsible party
- Principal investigator, Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
- Investigators
- EDGAR CARVALHO, MD, PhD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011343
- Sponsor's protocol ID
- CL Tofa23
- Acronym
- CLTofa23
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tofacitinib Associated With Meglumine Antimoniate in the Control of American Tegumentary Leishmaniasis. A Randomized and Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06011343
- Acronym / sponsor ID
- CLTofa23 / CL Tofa23
- Conditions
- Cutaneous Leishmaniasis, American
- Keywords
- Cutaneous Leishmaniasis, meglumine antimoniate, tofacitinib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Collaborators
- Instituto Gonçalo Muniz FIOCRUZ BA
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 25 Aug 2023 (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.
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
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- CL patients will be allocated in 2 intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Placebo and Sbv | Placebo comparator | Drug: Parenteral meglumine antimoniateEleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days. |
| Tofacitinib and Sbv | Experimental | Drug: Oral tofacitinib, Drug: Parenteral meglumine antimoniateEleven 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Oral tofacitinibAssociation of tofacitinib and meglumine antimoniate | Drug | Tofacitinib and Sbv |
| Parenteral meglumine antimoniateMeglumine antimoniate | Drug | Placebo and Sbv, Tofacitinib and Sbv |
Primary outcome
Cure at 90 days
Time frame: 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.
3 secondary outcomes
Cure at 180 days
Time frame: 180 days
Time to cure
Time frame: Days
Adverse events
Time frame: 45 dyas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
EDGAR CARVALHO, MD, PhD principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral tofacitinib and Parenteral meglumine antimoniate in people with Cutaneous Leishmaniasis, American, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EDGAR L CARVALHO, MD, PhD (7132377353, imuno@ufba.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure at 90 days (time frame: 90 days). 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 25 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.