Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Étude de phase 2a sur l'efficacité et l'innocuité de l'OpSCF dans la dermatite atopique modérée à sévère

17 août 2026 mis à jour par: Insmed Incorporated

Une étude de phase 2a randomisée, en double aveugle, contrôlée par placebo, pour évaluer l'efficacité et l'innocuité de l'OpSCF dans le traitement de sujets adultes atteints de dermatite atopique modérée à sévère

Le but de cette étude est de déterminer l'efficacité et l'innocuité d'un anticorps monoclonal, OpSCF, dans le traitement des adultes atteints de dermatite atopique (eczéma) modérée à sévère. OpSCF sera comparé à un placebo.

OpSCF ou un placebo seront administrés toutes les 2 semaines pendant 14 semaines, et l'efficacité sera évaluée deux semaines plus tard. Après cela, les sujets peuvent choisir d'entrer dans une phase d'extension ouverte au cours de laquelle tous les sujets recevront OpSCF toutes les 4 semaines pendant 40 semaines supplémentaires.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

50

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic Dermatology Trials
      • Toronto, Ontario, Canada, M4W 2N2
        • Research Toronto
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research Inc
      • Québec, Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 33607
        • Cahaba Dermatology & Skin Health Center
    • California
      • Fountain Valley, California, États-Unis, 92708
        • First OC Dermatology Research
      • Inglewood, California, États-Unis, 90301
        • Axon Clinical Research
      • San Diego, California, États-Unis, 92123
        • University Clinical Trials
      • Sherman Oaks, California, États-Unis, 91403
        • Unison Clinical Trials
    • Florida
      • Boca Raton, Florida, États-Unis, 33456
        • Skin Care Research
      • Miami, Florida, États-Unis, 33173
        • Skin Research of South Florida
      • Miami Lakes, Florida, États-Unis, 33014
        • RM Medical Research
      • Tampa, Florida, États-Unis, 33607
        • Advanced Clinical Research Institute
    • Illinois
      • Rolling Meadows, Illinois, États-Unis, 60008
        • Arlington Dermatology
    • Indiana
      • West Lafayette, Indiana, États-Unis, 47906
        • Options Research Group
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40241
        • DS Research of Kentucky
    • Michigan
      • Auburn Hills, Michigan, États-Unis, 48326
        • Oakland Hills Dermatology P.C
      • Bay City, Michigan, États-Unis, 48706
        • Saginaw Bay Dermatology
    • Nevada
      • Reno, Nevada, États-Unis, 89509
        • Skin Cancer and Dermatology Institute
    • New York
      • Kew Gardens, New York, États-Unis, 11415
        • Forest Hills Dermatology Group
    • Texas
      • Frisco, Texas, États-Unis, 75034
        • Rodgers Dermatology
    • Washington
      • Bellevue, Washington, États-Unis, 98004
        • Dermatology Of Seattle

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Le sujet a un diagnostic cliniquement confirmé de MA active
  • Le sujet a des antécédents de MA depuis au moins 6 mois
  • Le sujet est prêt à utiliser une méthode contraceptive efficace

Critère d'exclusion:

  • Le sujet est une femme qui allaite, est enceinte ou qui envisage de devenir enceinte pendant l'étude.
  • Le sujet présente un problème de santé cliniquement significatif qui exposerait le sujet à un risque excessif ou interférerait avec l'interprétation des résultats de l'étude.
  • Le sujet a utilisé du dupilumab dans les 26 semaines précédant le premier jour.
  • Le sujet a utilisé du tralokinumab dans les 12 semaines précédant le premier jour.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: OpSCF 600 mg
Participants received OpSCF 600 milligrams (mg), once every 2 weeks (Q2W), subcutaneously (SC), up to 14 weeks in the placebo-controlled period.
Biologique: OpSCF
Administered SC.
Autres noms:
  • Humanized IgG4k, SCF248
Comparateur placebo: OpSCF Matching-Placebo
Participants received OpSCF matching-placebo, Q2W, SC, up to 14 weeks in the placebo-controlled period.
Biologique: Placebo
Administered SC.
Expérimental: OpSCF 600 mg/OpSCF 600mg
Participants who received OpSCF 600 mg and completed placebo-controlled treatment received OpSCF 600mg, once every 4 weeks (Q4W), SC, up to 36 weeks in the open-label extension (OLE) period.
Biologique: OpSCF
Administered SC.
Autres noms:
  • Humanized IgG4k, SCF248
Biologique: Placebo
Administered SC.
Comparateur placebo: OpSCF Matching-Placebo/OpSCF 600 mg
Participants who received OpSCF matching-placebo and completed placebo-controlled treatment received OpSCF 600mg, Q4W, SC, up to 36 weeks in the OLE period.
Biologique: OpSCF
Administered SC.
Autres noms:
  • Humanized IgG4k, SCF248
Biologique: Placebo
Administered SC.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16
Délai: Baseline, Week 16
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
Baseline, Week 16

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants Who Experienced At-Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Events (SAEs)
Délai: From first dose of study drug up to end of follow-up (up to Week 67)
An adverse event (AE) was any untoward medical occurrence in participant administered a pharmaceutical product & that does not necessarily have a causal relationship with this treatment. It can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study product, whether or not considered related to the study product. An SAE was any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity & was a congenital anomaly/birth defect. Any AE starting on or after the first dose date will be considered TEAE.
From first dose of study drug up to end of follow-up (up to Week 67)
Percent Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, and 14
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
Baseline, Weeks 2, 4, 6, 8, 10, 12 and 14
Change From Baseline in EASI at Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies the severity of a participant's AD based on both lesion severity and the % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%). The EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least 50% Improvement From Baseline in EASI (EASI50)
Délai: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 50 response was defined as at least a 50% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least 75% Improvement From Baseline in EASI (EASI75)
Délai: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 75 response was defined as at least a 75% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least 90% Improvement From Baseline in EASI (EASI90)
Délai: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The EASI quantifies severity of a participant's AD based on both lesion severity & % of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I], excoriation[Ex] & lichenification[L]) was scored separately for each of 4 body regions[head(h), upper extremities(u), trunk(t), lower extremities(l)] on a 4-point scale:0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based on % BSA with AD in body region: 0(no involvement), 1(< 10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) & 6(90 to 100%). EASI score is obtained as: EASI(A) = 0.1*(Eh+Ih+Exh+Lh)*Ah + 0.2*(Eu+Iu+Exu+Lu)*Au + 0.3*(Et +It+Ext+Lt)*At + 0.4*(El+Il+Exl+Ll)*Al. Total EASI score = 0.0 to 72.0; higher scores indicate greater severity of AD. Here, a negative change from baseline indicates less severity in AD. EASI 90 response was defined as at least a 90% improvement in EASI relative to Baseline. 90% CI was based on exact Clopper-Pearson method.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Délai: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions. It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification. Percentage of participants who achieved at least a 2-grade reduction from baseline to clear (0) or Almost Clear (1) in vIGA-AD are reported here.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least a 2-grade Reduction From Baseline in vIGA-AD
Délai: At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The vIGA-AD was assessed by the principal investigator or sub-investigator using the descriptors that best described the overall appearance of the lesions. It is a 5-point morphological assessment of overall disease severity that ranges from 0 to 4, where 0 = Clear; No inflammatory signs of atopic dermatitis 1 = Almost clear; Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification 2 = Mild; Slight but definite erythema (pink), slight but definite induration/papulation, and/ or slight but definite lichenification 3 = Moderate; Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification 4 = Severe; Marked erythema (deep or bright red), marked induration/ papulation, and/or marked lichenification. The percentage of participants with reduction from baseline of ≥2 grade in vIGA-AD score has been reported.
At Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in Weekly Average of the Daily Peak Pruritus Numeric Rating Scale (PP-NRS)
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percent Change From Baseline in Weekly Average of the Daily PP-NRS
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percentage of Participants Achieving At-Least a 4-point Reduction From Baseline in Weekly Average of the Daily PP-NRS
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
PP-NRS is based on the Numeric Rating Scale which was used to assess the level of itch the participant was experiencing. The following question was be asked to participants: "On a scale of 0 to 10, with 0 = "no itch" and 10 = "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?" Based on the score provided by participant, the PP-NRS score was assigned. Higher score indicates more severity. A negative change from Baseline indicates improvement. The percentage of participants who had at least a 4-point reduction in the NRS score at post-baseline visits has been reported.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The overall BSA affected by AD was evaluated (from 0% to 100%). It was calculated using the palm surface area method. This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Percent Change From Baseline in BSA Involved With AD
Délai: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
The overall BSA affected by AD was evaluated (from 0% to 100%). It was calculated using the palm surface area method. This method states that palmar surface of 1 hand (using the participant's hand and including the fingers) represents 1% of his or her total BSA.
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16
Change From Baseline in Atopic Dermatitis Control Tool (ADCT) at Weeks 2, 4, 8, 12, and 16
Délai: Baseline, Weeks 2, 4, 8,12 and 16
ADCT questionnaire is a self-assessment comprised of 6 concise questions to evaluate participant's perceptions of AD symptoms and impacts on their life and function over the last week. Each question carries equal weight and is scored from 0 to 4, for a total score ranging between 0 and 24. Higher score indicates higher severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 8,12 and 16
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Weeks 2, 4, 8, 12, and 16
Délai: Baseline, Weeks 2, 4, 8,12 and 16
POEM is a self-assessment of disease severity using 7 questions asked to participant. A maximum value of 28 can be assigned based on the participant's response to 7 questions scored from 0 to 4, where 0 = No days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days and 4 = Every day. Higher score indicates high severity. A negative change from baseline indicates improvement.
Baseline, Weeks 2, 4, 8,12 and 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12, and 16
Délai: Baseline, Weeks 2, 4, 8,12 and 16
DLQI is a 10 questions questionnaire to measure how much skin problems have affected a participant's life over the last week. Each question is scored from 0 to 3 (0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much). The DLQI is calculated by summing the score of each question, giving a total score ranging from 0 (not at all) to 30 (very much). The higher the score the more quality of life is impaired. A negative change from baseline indicates improvement in QoL.
Baseline, Weeks 2, 4, 8,12 and 16
Placebo-controlled Period: Serum Concentrations of OpSCF Over Time
Délai: Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
Days 15, 29, 43, 57, 85, 99, 102, 106 and 113
OLE Period: Serum Concentrations of OpSCF Over Time
Délai: Days 141, 169, 197, 225, 253, 281, 309 and 337
Days 141, 169, 197, 225, 253, 281, 309 and 337

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Changement par rapport à la valeur initiale des biomarqueurs sanguins et des IgE aux semaines 4, 8, 12 et 16
Délai: 16 semaines
Des analyses de sang
16 semaines
Changement par rapport à la valeur initiale des biomarqueurs cutanés collectés à l'aide de biopsies cutanées aux semaines 4 et 16 (facultatif pour les sujets consentants)
Délai: 16 semaines
Examen histopathologique
16 semaines
Changement par rapport à la valeur initiale des biomarqueurs cutanés collectés à l'aide de bandes de ruban adhésif aux semaines 4 et 16 (facultatif pour les sujets consentants)
Délai: 16 semaines
Analyse des niveaux de protéomique et d'ARNm
16 semaines

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Insmed Incorporated

Collaborateurs

Innovaderm Research Inc.

Les enquêteurs

  • Directeur d'études: Study Director, Insmed Incorporated

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 novembre 2023

Achèvement primaire (Réel)

3 septembre 2024

Achèvement de l'étude (Réel)

18 août 2025

Dates d'inscription aux études

Première soumission

19 octobre 2023

Première soumission répondant aux critères de contrôle qualité

25 octobre 2023

Première publication (Réel)

26 octobre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OpSCF-201

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner