Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Farmakokinetik, sikkerhed og effekt af Nemolizumab hos deltagere med moderat til svær atopisk dermatitis

1. juni 2026 opdateret af: Galderma R&D

Et multicenter, åbent, enkeltgruppe klinisk forsøg til vurdering af farmakokinetikken, sikkerheden og effektiviteten af ​​Nemolizumab (CD14152) hos pædiatriske forsøgspersoner (i alderen 2 til 11 år) med moderat til svær atopisk dermatitis

Formålet med denne undersøgelse er at vurdere farmakokinetikken (PK), effektiviteten og sikkerheden af ​​nemolizumab hos pædiatriske deltagere med moderat til svær atopisk dermatitis (AD).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

109

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Hellerup, Danmark, 2900
        • Galderma Investigational Site #6218
  • Forenede Stater
    • California
      • Fountain Valley, California, Forenede Stater, 92708-3701
        • Galderma Investigational Site #8636
      • San Diego, California, Forenede Stater, 92123-2746
        • Galderma Investigational Site #9937
      • Vista, California, Forenede Stater, 92083-6031
        • Galderma Investigational Site #9930
    • Florida
      • Coral Gables, Florida, Forenede Stater, 92083-6031
        • Galderma Investigational Site #9929
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250-2041
        • Galderma Investigational Site #8142
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40217-1444
        • Galderma Investigational Site #8092
    • Michigan
      • Troy, Michigan, Forenede Stater, 48084-5260
        • Galderma Investigational Site #8155
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Galderma Investigational Site #8560
    • New York
      • Brooklyn, New York, Forenede Stater, 11203-2012
        • Galderma Investigational Site #8242
      • New York, New York, Forenede Stater, 10032-3729
        • Galderma Investigational Site #9938
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73069-6301
        • Galderma Investigational Site #8206
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19103-4708
        • Galderma Investigational Site #8255
    • Texas
      • Beaumont, Texas, Forenede Stater, 77706-3061
        • Galderma Investigational Site #9931
      • San Antonio, Texas, Forenede Stater, 78218-3128
        • Galderma Investigational Site #78218-3128
  • Polen
      • Lodz, Polen, 90-265
        • Galderma Investigational Site #5570
      • Ostrowiec Świętokrzyski, Polen, 27-400
        • Galderma Investigational Site #6237
      • Rzeszów, Polen, 35-055
        • Galderma Investigational Site #5495
      • Warsaw, Polen, 02-953
        • Galderma Investigational Site #6262
      • Wroclaw, Polen, 51-685
        • Galderma Investigational Site #6261
  • Spanien
      • Esplugues de Llobregat, Spanien, 0850
        • Galderma Investigational Site #5896
  • Ungarn
      • Budapest, Ungarn, 1036
        • Galderma Investigational Site #6147
      • Szeged, Ungarn, 6720
        • Galderma Investigational Site #5531

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Kronisk AD, der har været dokumenteret i mindst 6 måneder for deltagere i alderen 2-6 år og mindst 1 år for deltagere i alderen 7-11 år før screeningsbesøget og bekræftet i henhold til American Academy of Dermatology Consensus Criteria på tidspunktet for screeningsbesøg
  • EASI-score >=16 ved både screenings- og baselinebesøg
  • IGA-score >=3 ved både screenings- og baselinebesøg
  • AD-involvering >=10 % af BSA ved både screening og baselinebesøg
  • Peak (maksimum) PP NRS-score på mindst 4,0 ved både screening og baselinebesøg
  • Aftal at påføre en fugtighedscreme under hele undersøgelsen fra screeningsbesøget dagligt og rigeligt efter behov; accepterer at anvende et godkendt topisk kortikosteroid (TCS) fra screeningsbesøget og under hele undersøgelsen som bestemt passende af investigator
  • Deltager og omsorgsperson, der er villig og i stand til at overholde alle tidsforpligtelser og procedurekrav i protokollen om kliniske forsøg
  • Andre protokoldefinerede inklusionskriterier kan være gældende

Ekskluderingskriterier:

  • Kropsvægt mindre end 10 kg (kg)
  • Forsorgsbarn: et barn, der er blevet sat under kontrol eller beskyttelse af en agentur, organisation, institution eller enhed af domstolene, regeringen eller et regeringsorgan, der handler i overensstemmelse med beføjelser, som er tildelt dem ved lov eller forskrift
  • Deltagere med en aktuel sygehistorie med kronisk bronkitis
  • Kræver redningsterapi for AD i indkøringsperioden eller forventes at kræve redningsterapi inden for 2 uger efter baseline-besøget
  • Positive serologiske resultater for hepatitis B overfladeantigen (HBsAg) eller hepatitis B kerneantistof (HBcAb), hepatitis C (HCV) antistof med positiv bekræftende test for HCV (eksempel; polymerasekædereaktion [PCR]) eller human immundefektvirus (HIV) antistof ved screeningsbesøget
  • Anamnese med lymfoproliferativ sygdom, overfølsomhed (herunder anafylaksi) over for et immunglobulinprodukt og intolerance over for topikale kortikosteroider med lav eller middel styrke
  • Kendt eller mistænkt immunsuppression
  • Deltagere, der ikke er villige til at afholde sig fra at bruge forbudt medicin under det kliniske forsøg.
  • Andre protokoldefinerede udelukkelseskriterier kan være gældende

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kohorte 2: Deltagere i alderen 2-6 år
Deltagere i alderen 2-6 år får nemolizumab i 52 uger.
Medicin: Nemolizumab
Deltagerne vil modtage subkutan (SC) injektion af 10, 20 eller 30 milligram (mg) nemolizumab hver 4. uge (Q4W) i 52 uger med en startdosis på 20, 40 eller 60 mg på dag 1 baseret på kropsvægten.
Andre navne:
  • CD14152
Medicin: Nemolizumab
Deltagerne vil modtage SC-injektion af 5, 10 eller 15 mg nemolizumab, Q4W i 52 uger med en startdosis på 10, 20 eller 30 mg på dag 1 baseret på kropsvægten.
Andre navne:
  • CD14152
Eksperimentel: Kohorte 1.1: Deltagere i alderen 7-11 år
Deltagere i alderen 7-11 år får nemolizumab i 52 uger.
Medicin: Nemolizumab
Deltagerne vil modtage subkutan (SC) injektion af 10, 20 eller 30 milligram (mg) nemolizumab hver 4. uge (Q4W) i 52 uger med en startdosis på 20, 40 eller 60 mg på dag 1 baseret på kropsvægten.
Andre navne:
  • CD14152
Medicin: Nemolizumab
Deltagerne vil modtage SC-injektion af 5, 10 eller 15 mg nemolizumab, Q4W i 52 uger med en startdosis på 10, 20 eller 30 mg på dag 1 baseret på kropsvægten.
Andre navne:
  • CD14152
Eksperimentel: Kohort 1: Deltagere i alderen 7-11 år
Deltagere i alderen 7-11 år vil modtage nemolizumab i 52 uger.
Medicin: Nemolizumab
Deltagerne vil modtage subkutan (SC) injektion af 10, 20 eller 30 milligram (mg) nemolizumab hver 4. uge (Q4W) i 52 uger med en startdosis på 20, 40 eller 60 mg på dag 1 baseret på kropsvægten.
Andre navne:
  • CD14152
Medicin: Nemolizumab
Deltagerne vil modtage SC-injektion af 5, 10 eller 15 mg nemolizumab, Q4W i 52 uger med en startdosis på 10, 20 eller 30 mg på dag 1 baseret på kropsvægten.
Andre navne:
  • CD14152

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nemolizumab Serum Concentrations
Tidsramme: At Weeks 4, 8, 12, 16, 32 and 52
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
At Weeks 4, 8, 12, 16, 32 and 52
Apparent Total Body Clearance (Cl/F) of Nemolizumab
Tidsramme: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
CL/F is apparent clearance of the drug from the serum, calculated as the drug dose divided area under the curve from time 0 extrapolated to infinite time [AUC (0-inf)]. Individual nemolizumab.
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Volume of Distribution (Vd/F) of Nemolizumab
Tidsramme: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Vd/F was calculated as dose divided by lambda_z *AUC(0-inf).
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Absorption Rate Constant (Ka) of Nemolizumab
Tidsramme: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
Tidsramme: Pre-dose at Weeks 4, 8, 12, and 16
Pre-dose at Weeks 4, 8, 12, and 16
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
Tidsramme: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab
Tidsramme: Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Pre-dose at Weeks 4, 8, 12, 16, 32 and 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs)
Tidsramme: Baseline through Week 52
AE defined as any untoward medical occurrence in clinical study participant administered a medicinal product which does not necessarily have causal relationship with this treatment. TEAEs defined as AEs occurring after first administration of study drug during the study. SAE was any untoward medical occurrence, in view of either Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was important medical event. AESI was noteworthy TEAE for study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. AEs Leading to study treatment withdrawal and AEs Leading to study withdrawal will also be reported.
Baseline through Week 52

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in EASI Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants Achieving 50 Percent (%), 75% or 90% Response From Baseline in EASI (EASI-50, EASI-75 and EASI-90)
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
EASI assesses severity and extent of AD signs through a composite score of erythema, induration/population, excoriation, and lichenification. The severity was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. The EASI score ranged from 0 to 72 with higher scores representing greater severity of atopic dermatitis. EASI-50, EASI-75 and EASI-90 responders will be the participants who achieved greater than or equal to (>=) 50%, >=75% and >=90% overall improvement in EASI score respectively from baseline to Week 52.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Investigator's Global Assessment (IGA) Success Rate
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of AD. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Here, higher score indicates severe outcome. Success was defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >=2-points improvement from baseline. Number of participants with IGA success rate was reported for this outcome measure.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that will be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of PP NRS Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants With an Improvement of >= 4 From Baseline in Weekly Average of PP NRS
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Average Pruritus NRS Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Average Pruritus NRS Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Absolute Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percent Change From Baseline in Weekly Average of Sleep Disturbance NRS Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicated worse outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Percentage of Participants Receiving Any Rescue Therapy by Rescue Treatment
Tidsramme: From Baseline up to Week 52
Percentage of participants receiving any rescue therapy by rescue treatment was reported.
From Baseline up to Week 52
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Tidsramme: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
SCORAD is a clinical tool for assessing the severity and the extent of AD signs and symptoms. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease), a higher score indicated severe disease.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age
Tidsramme: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer quality of life (QoL).
Baseline, Week 16 and Week 52
Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) Score For Participants Less Than (<) 4 Years of Age
Tidsramme: Baseline, Week 16 and Week 52
The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant rated each question ranging from 0 (not at all) to 3 (very much) and score ranged from 0 to 30. A higher total score indicated a poorer QoL.
Baseline, Week 16 and Week 52
Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Tidsramme: Baseline, Week 16 and Week 52
The POEM is a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A high score indicated poor QOL.
Baseline, Week 16 and Week 52
Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in PP NRS
Tidsramme: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in PP-NRS score was established using population point estimate of IC50, where IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in PP NRS.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in EASI Score
Tidsramme: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in EASI score was established using population point estimate of IC50. Where, IC50 is the concentration leading to half of the maximum drug-induced reduction (Imax) in EASI score.
Baseline up to Week 52
PK/PD Relationship Between Nemolizumab Serum Concentration and Changes in IGA Score
Tidsramme: Baseline up to Week 52
The relationship between nemolizumab serum concentrations and changes in IGA score was established using the population point estimate of the slope parameter.
Baseline up to Week 52
Number of Participants With Positive Anti-Drug Antibody (ADA) for Nemolizumab
Tidsramme: Baseline, Week 16 and Week 52
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Baseline, Week 16 and Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Galderma R&D

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. juni 2021

Primær færdiggørelse (Faktiske)

28. april 2025

Studieafslutning (Faktiske)

28. april 2025

Datoer for studieregistrering

Først indsendt

4. juni 2021

Først indsendt, der opfyldte QC-kriterier

4. juni 2021

Først opslået (Faktiske)

10. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RD.06.SPR.118126

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner