Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Phase II/III Study of FXS5626 in Participants With Non-segmental Vitiligo

24 de setembro de 2026 atualizado por: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

This is a Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive Seamless Design, Phase II/III Study Evaluating the Efficacy and Safety of FXS5626 in Participants With Non-segmental Vitiligo

This is a multicenter, randomized, double-blind, placebo-controlled, adaptive seamless design, Phase II/III study evaluating the efficacy and safety of FXS5626 in participants with non-segmental vitiligo.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a multicenter, randomized, double-blind, placebo-controlled, adaptive seamless design, Phase II/III study evaluating the efficacy and safety of FXS5626 in participants with non-segmental vitiligo. The study consisted 2 periods: a phase 2 period and a phase 3 period.

Phase 2 design: This period is planned to enroll 120 patients with non-segmental vitiligo. Eligible participants will be randomized in a 2:2:1:1 ratio to the FXS5626 75 mg twice daily (BID) group, the FXS5626 50 mg BID group, the FXS5626 25 mg BID group, or the placebo group, with 40, 40, 20, and 20 participants enrolled in each group, respectively. The overall study duration consists of a 4-week screening period, a 24-week double-blind treatment period, and a 4-week safety follow-up period.

Phase 3 design: This period is planned to enroll 360 patients with non-segmental vitiligo. Eligible participants will be randomized in a 2:1 ratio to the FXS5626 group and the placebo group. The overall study duration consists of a 4-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.

Tipo de estudo

Intervencional

Inscrição (Estimado)

480

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Wenyu Wu
  • Número de telefone: +86 021-52887783
  • E-mail: wwylcsy@163.com

Estude backup de contato

Locais de estudo

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital, Fudan University
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 75 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Participants must meet all of the following inclusion criteria:

  1. Understand the trial procedures and methods, voluntarily participate in this trial, be able to communicate well with the investigator, comply with the requirements of the entire study, and provide written informed consent;
  2. Screening age must meet the following criteria:

1) Age ≥18 years and ≤75 years, regardless sex (Phase 2); 2) Age ≥12 years and ≤75 years, regardless of sex (Phase 3); 3. At screening，participants must have a body mass index (BMI) ≥18 kg/m²; for adolescent participants in the Phase 3, baseline body weight must be ≥40 kg; 4. Clinically diagnosed with non-segmental vitiligo, either active or stable, with a disease history ≥3 months; 5. At the screening and baseline visits, vitiligo lesions must satisfy all of the following criteria:

  1. The percentage of vitiligo lesion area relative to the total body surface area (BSA) is ≥3%, excluding involvement of the palms, dorsa of the hands (fingers), soles, and dorsa of the feet;
  2. Facial involvement BSA (F-BSA) ≥0.5%;
  3. T-VASI ≥0.5 and 3 ≤ T-VASI ≤50; 6. Participants must ensure and agree that, from 28 days before signing the informed consent form to 28 days after the last dose, female participants of childbearing potential, male participants, and their spouses will use effective contraceptive methods other than oral medications (such as condoms or intrauterine devices), and will not donate sperm or ova during this study.

Exclusion Criteria

  1. Presence of vitiligo-related medical conditions and other skin diseases at screening, as assessed by the investigator;
  2. Presence of >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face);
  3. As assessed by the investigator, accompanied by active infection or history of infection;
  4. Patients with a history of severe herpes simplex and herpes zoster infections, or with active/current herpes simplex or herpes zoster infection;
  5. Participants with any other clinically significant medical history, or other conditions that, as assessed by the investigator, may affect the participant's safety or compliance, or result in the participant's inability to complete the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm1: FXS5626 25 mg (Phase 2)

FXS5626 25 mg
Medicamento: Intervention1: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Experimental: Arm2: FXS5626 50 mg (Phase 2)

FXS5626 50 mg
Medicamento: Intervention2: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Experimental: Arm3: FXS5626 75 mg (Phase 2)

FXS5626 75 mg
Medicamento: Intervention3: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 24 weeks.
Experimental: Arm4: FXS5626 group (Phase 3)

FXS5626 group (Dosage will be confirmed after Phase 2)
Medicamento: Intervention4: FXS5626 Tablets

FXS5626 tablets administered orally twice daily (BID) for 52 weeks.
Comparador de Placebo: Arm5: Placebo (Phase 2)

Placebo
Medicamento: Intervention5: FXS5626 Placebo Tablets

FXS5626 placebo tablets administered orally twice daily (BID) for 24 weeks.
Comparador de Placebo: Arm6: Placebo (Phase 3)

Placebo
Medicamento: Intervention6: FXS5626 Placebo Tablets

FXS5626 placebo tablets administered orally twice daily (BID) for 52 weeks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study.
Prazo: 24 weeks

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
24 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at Week 52 in Phase 3 study.
Prazo: 52 weeks

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome. F-VASI 75 denotes a at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
52 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits other than Week 24（Phase 2)
Prazo: 24 weeks

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
24 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at planned visits (Phase 2)
Prazo: 24 weeks

At least 75% improvement from baseline in facial Vitiligo Area Scoring Index. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
24 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50 (F-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)
Prazo: 24 weeks

At least 50% improvement from baseline in facial Vitiligo Area Scoring Index. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
24 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 90 (F-VASI 90, at least 90% improvement from baseline) at planned visits (Phase 2)
Prazo: 24 weeks

At least 90% improvement from baseline in facial Vitiligo Area Scoring Index. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
24 weeks
Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 2)
Prazo: 24 weeks

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)
Prazo: 24 weeks

At least 50% improvement from baseline in Total Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 75 (T-VASI 75, at least 75% improvement from baseline) at planned visits (Phase 2)
Prazo: 24 weeks

At least 75% improvement from baseline in Total Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
24 weeks
Change from baseline in the Facial Body Surface Area (F-BSA) affected by vitiligo at planned visits (Phase 2)
Prazo: 24 weeks

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
24 weeks
Change from baseline in the Total Body Surface Area (T-BSA) affected by vitiligo at planned visits (Phase 2)
Prazo: 24 weeks

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
24 weeks
Proportion of participants achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) at planned visits (Phase 2)
Prazo: 24 weeks

The F-PhGVA is an assessment tool used by physicians to evaluate the severity of facial vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
24 weeks
Proportion of participants achieving a score of 0 or 1 on the Total Physician's Global Vitiligo Assessment (T-PhGVA) at planned visits (Phase 2)
Prazo: 24 weeks

The T-PhGVA is a assessment tool used by physicians to evaluate the severity of total body vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
24 weeks
Proportion of participants achieving a score of 1 or 2 on the Facial Patient's Global Impression of Change-Vitiligo (F-PaGIC-V) at planned visits (Phase 2)
Prazo: 24 weeks

F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse）.
24 weeks
Proportion of participants achieving a score of 1 or 2 on the Total Body Patient's Global Impression of Change-Vitiligo (T-PaGIC-V) at planned visits (Phase 2)
Prazo: 24 weeks

T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
24 weeks
Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) at planned visits (Phase 2)
Prazo: 24 weeks

VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time")
24 weeks
Number of Participants with Adverse Events (AEs) (Phase 2)
Prazo: 24 weeks and 4 weeks

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AE severity was assessed as mild, moderate and severe. Mild: Transient discomfort, no interference with daily activities, and/or no medical intervention required. Moderate: Mild to moderate limitation of daily activities, and/or minimal medical intervention required. Severe: Marked limitation of daily activities, requiring assistance with activities of daily living, and/or medical intervention required, possibly hospitalization.
24 weeks and 4 weeks
Plasma concentrations of FXS5626 and its metabolite TT-190 (Phase 2)
Prazo: 24 weeks
24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at Week 52 (Phase 3)
Prazo: 52 weeks

At least 50% improvement from baseline in total body Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
52 weeks
Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits (Phase 3)
Prazo: 52 weeks

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
52 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 50 (F-VASI 50) at planned visits (Phase 3)
Prazo: 52 weeks

At least 50% improvement from baseline in facial Vitiligo Area Scoring Index. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
52 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75) at planned visits other than Week 52 (Phase 3)
Prazo: 52 weeks

At least 75% improvement from baseline in facial Vitiligo Area Scoring Index. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
52 weeks
Proportion of participants achieving Facial Vitiligo Area Scoring Index 90 (F-VASI 90) at planned visits (Phase 3)
Prazo: 52 weeks

At least 90% improvement from baseline in facial Vitiligo Area Scoring Index. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
52 weeks
Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 3)
Prazo: 52 weeks

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
52 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at planned visits other than Week 52 (Phase 3)
Prazo: 52 weeks

At least 50% improvement from baseline in total body Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
52 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 75 (T-VASI 75) at planned visits (Phase 3)
Prazo: 52 weeks

At least 75% improvement from baseline in total body Vitiligo Area Scoring Index. The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
52 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 90 (T-VASI 90) at planned visits (Phase 3)
Prazo: 52 weeks

At least 90% improvement from baseline in facial Vitiligo Area Scoring Index.The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. Higher scores of T-VASI mean a worse outcome.
52 weeks
Change from baseline in the F-BSA affected by vitiligo at planned visits (Phase 3)
Prazo: 52 weeks

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
52 weeks
Change from baseline in the T-BSA affected by vitiligo at planned visits (Phase 3)
Prazo: 52 weeks

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA.
52 weeks
Proportion of participants achieving a score of 0 or 1 on the F-PhGVA at planned visits (Phase 3)
Prazo: 52 weeks

The F-PhGVA is an assessment tool used by physicians to evaluate the severity of facial vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
52 weeks
Proportion of participants achieving a score of 0 or 1 on the T-PhGVA at planned visits (Phase 3)
Prazo: 52 weeks

The T-PhGVA is a assessment tool used by physicians to evaluate the severity of total body vitiligo. It is rated on a 4-point scale: overall improvement: (0) no change, (1)limited extent, (2)moderate extent, (3)extensive, (4)very extensive. Higher score corresponds to worse evaluation.
52 weeks
Proportion of participants achieving score of 1 or 2 on the a F-PaGIC-V at planned visits (Phase 3)
Prazo: 52 weeks

F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
52 weeks
Proportion of participants achieving a score of 1 or 2 on the T-PaGIC-V at planned visits (Phase 3)
Prazo: 52 weeks

T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).
52 weeks
Change from baseline in the VitiQoL at planned visits (Phase 3)
Prazo: 52 weeks

VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time")
52 weeks
Change from baseline in the Dermatology Life Quality Index (DLQI)) at planned visits (Phase 3)
Prazo: 52 weeks

DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
52 weeks
Proportion of participants achieving a DLQI total score of "0" or "1"at planned visits (Phase 3)
Prazo: 52 weeks

DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
52 weeks
Proportion of participants achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) at planned visits (Phase 3)
Prazo: 52 weeks

The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable. higher score corresponds to worse symptom impact.
52 weeks
Number of Participants with Adverse Events (AEs) (Phase 3)
Prazo: 52 weeks and 4 weeks

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AE severity was assessed as mild, moderate and severe. Mild: Transient discomfort, no interference with daily activities, and/or no medical intervention required. Moderate: Mild to moderate limitation of daily activities, and/or minimal medical intervention required. Severe: Marked limitation of daily activities, requiring assistance with activities of daily living, and/or medical intervention required, possibly hospitalization.
52 weeks and 4 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de outubro de 2026

Conclusão Primária (Estimado)

10 de novembro de 2027

Conclusão do estudo (Estimado)

8 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

17 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de setembro de 2026

Primeira postagem (Real)

25 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • FXS5626-VIT-301

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever