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

24 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

480

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Wenyu Wu
  • Numero di telefono: +86 021-52887783
  • Email: wwylcsy@163.com

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200040
        • Huashan Hospital, Fudan University
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 75 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm1: FXS5626 25 mg (Phase 2)

FXS5626 25 mg
Droga: Intervention1: FXS5626 Tablets

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

FXS5626 50 mg
Droga: Intervention2: FXS5626 Tablets

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

FXS5626 75 mg
Droga: Intervention3: FXS5626 Tablets

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

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

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

Placebo
Droga: Intervention5: FXS5626 Placebo Tablets

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

Placebo
Droga: Intervention6: FXS5626 Placebo Tablets

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study.
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits other than Week 24（Phase 2)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 24 weeks
24 weeks
Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at Week 52 (Phase 3)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 ottobre 2026

Completamento primario (Stimato)

10 novembre 2027

Completamento dello studio (Stimato)

8 dicembre 2027

Date di iscrizione allo studio

Primo inviato

17 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 settembre 2026

Primo Inserito (Effettivo)

25 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • FXS5626-VIT-301

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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