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Farmakokinetikk, sikkerhet og effekt av Nemolizumab hos deltakere med moderat til alvorlig atopisk dermatitt

1. juni 2026 oppdatert av: Galderma R&D

En multisenter, åpen, enkeltgruppe klinisk studie for å vurdere farmakokinetikken, sikkerheten og effektiviteten til Nemolizumab (CD14152) hos pediatriske personer (i alderen 2 til 11 år) med moderat til alvorlig atopisk dermatitt

Hensikten med denne studien er å vurdere farmakokinetikken (PK), effektiviteten og sikkerheten til nemolizumab hos pediatriske deltakere med moderat til alvorlig atopisk dermatitt (AD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

109

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Hellerup, Danmark, 2900
        • Galderma Investigational Site #6218
  • Forente stater
    • California
      • Fountain Valley, California, Forente stater, 92708-3701
        • Galderma Investigational Site #8636
      • San Diego, California, Forente stater, 92123-2746
        • Galderma Investigational Site #9937
      • Vista, California, Forente stater, 92083-6031
        • Galderma Investigational Site #9930
    • Florida
      • Coral Gables, Florida, Forente stater, 92083-6031
        • Galderma Investigational Site #9929
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46250-2041
        • Galderma Investigational Site #8142
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40217-1444
        • Galderma Investigational Site #8092
    • Michigan
      • Troy, Michigan, Forente stater, 48084-5260
        • Galderma Investigational Site #8155
      • West Bloomfield, Michigan, Forente stater, 48322
        • Galderma Investigational Site #8560
    • New York
      • Brooklyn, New York, Forente stater, 11203-2012
        • Galderma Investigational Site #8242
      • New York, New York, Forente stater, 10032-3729
        • Galderma Investigational Site #9938
    • Oklahoma
      • Norman, Oklahoma, Forente stater, 73069-6301
        • Galderma Investigational Site #8206
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19103-4708
        • Galderma Investigational Site #8255
    • Texas
      • Beaumont, Texas, Forente stater, 77706-3061
        • Galderma Investigational Site #9931
      • San Antonio, Texas, Forente 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
  • Spania
      • Esplugues de Llobregat, Spania, 0850
        • Galderma Investigational Site #5896
  • Ungarn
      • Budapest, Ungarn, 1036
        • Galderma Investigational Site #6147
      • Szeged, Ungarn, 6720
        • Galderma Investigational Site #5531

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Kronisk AD som har vært dokumentert i minst 6 måneder for deltakere i alderen 2-6 år og minst 1 år for deltakere i alderen 7-11 år før screeningbesøket og bekreftet i henhold til American Academy of Dermatology Consensus Criteria på tidspunktet for visningsbesøk
  • EASI-score >=16 både ved screening og baseline-besøk
  • IGA-score >=3 ved både screening- og baseline-besøk
  • AD-involvering >=10 % av BSA ved både screening og baseline-besøk
  • Maksimal (maksimal) PP NRS-score på minst 4,0 ved både screening og baseline-besøk
  • Godta å bruke en fuktighetskrem gjennom hele studien fra screeningbesøket daglig, og rikelig etter behov; godta å bruke en autorisert topikale kortikosteroider (TCS) fra screeningbesøket og gjennom hele studien som bestemt av etterforskeren
  • Deltaker og omsorgsperson som er villig og i stand til å overholde alle tidsforpliktelser og prosedyrekrav i den kliniske utprøvingsprotokollen
  • Andre protokolldefinerte inklusjonskriterier kan gjelde

Ekskluderingskriterier:

  • Kroppsvekt mindre enn 10 kg (kg)
  • Barn i omsorg: et barn som har blitt plassert under kontroll eller beskyttelse av en byrå, organisasjon, institusjon eller enhet av domstolene, regjeringen eller et statlig organ, som handler i samsvar med fullmakter som er gitt dem ved lov eller forskrift
  • Deltakere med en aktuell medisinsk historie med kronisk bronkitt
  • Krever redningsterapi for AD i løpet av innkjøringsperioden eller forventes å kreve redningsterapi innen 2 uker etter baseline-besøket
  • Positive serologiresultater for hepatitt B overflateantigen (HBsAg) eller hepatitt B kjerneantistoff (HBcAb), hepatitt C (HCV) antistoff med positiv bekreftende test for HCV (eksempel; polymerasekjedereaksjon [PCR]), eller humant immunsviktvirus (HIV) antistoff ved screeningbesøket
  • Anamnese med lymfoproliferativ sykdom, overfølsomhet (inkludert anafylaksi) overfor et immunglobulinprodukt og intoleranse mot topikale kortikosteroider med lav eller middels styrke
  • Kjent eller mistenkt immunsuppresjon
  • Deltakere som ikke er villige til å avstå fra å bruke forbudte medisiner under den kliniske utprøvingen.
  • Andre protokolldefinerte eksklusjonskriterier kan gjelde

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Kohort 2: Deltakere i alderen 2-6 år
Deltakere i alderen 2-6 år vil få nemolizumab i 52 uker.
Legemiddel: Nemolizumab
Deltakerne vil få subkutan (SC) injeksjon av 10, 20 eller 30 milligram (mg) nemolizumab, hver 4. uke (Q4W) i 52 uker med en startdose på 20, 40 eller 60 mg på dag 1 basert på kroppsvekten.
Andre navn:
  • CD14152
Legemiddel: Nemolizumab
Deltakerne vil få SC-injeksjon av 5, 10 eller 15 mg nemolizumab, Q4W i 52 uker med en startdose på 10, 20 eller 30 mg på dag 1 basert på kroppsvekten.
Andre navn:
  • CD14152
Eksperimentell: Kohort 1.1: Deltakere i alderen 7-11 år
Deltakere i alderen 7-11 år vil få nemolizumab i 52 uker.
Legemiddel: Nemolizumab
Deltakerne vil få subkutan (SC) injeksjon av 10, 20 eller 30 milligram (mg) nemolizumab, hver 4. uke (Q4W) i 52 uker med en startdose på 20, 40 eller 60 mg på dag 1 basert på kroppsvekten.
Andre navn:
  • CD14152
Legemiddel: Nemolizumab
Deltakerne vil få SC-injeksjon av 5, 10 eller 15 mg nemolizumab, Q4W i 52 uker med en startdose på 10, 20 eller 30 mg på dag 1 basert på kroppsvekten.
Andre navn:
  • CD14152
Eksperimentell: Kohort 1: Deltakere i alderen 7-11 år
Deltakere i alderen 7-11 år vil motta nemolizumab i 52 uker.
Legemiddel: Nemolizumab
Deltakerne vil få subkutan (SC) injeksjon av 10, 20 eller 30 milligram (mg) nemolizumab, hver 4. uke (Q4W) i 52 uker med en startdose på 20, 40 eller 60 mg på dag 1 basert på kroppsvekten.
Andre navn:
  • CD14152
Legemiddel: Nemolizumab
Deltakerne vil få SC-injeksjon av 5, 10 eller 15 mg nemolizumab, Q4W i 52 uker med en startdose på 10, 20 eller 30 mg på dag 1 basert på kroppsvekten.
Andre navn:
  • CD14152

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Galderma R&D

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juni 2021

Primær fullføring (Faktiske)

28. april 2025

Studiet fullført (Faktiske)

28. april 2025

Datoer for studieregistrering

Først innsendt

4. juni 2021

Først innsendt som oppfylte QC-kriteriene

4. juni 2021

Først lagt ut (Faktiske)

10. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RD.06.SPR.118126

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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