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Een onderzoek naar TAK-279 bij volwassen deelnemers met gegeneraliseerde pustulaire psoriasis of erythrodermische psoriasis

14 oktober 2026 bijgewerkt door: Takeda

Een fase 3, open-label, multicenter onderzoek om de werkzaamheid, veiligheid en verdraagbaarheid van TAK-279 bij volwassen proefpersonen met gegeneraliseerde pustuleuze psoriasis of erytrodermische psoriasis te evalueren

The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.

All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.

Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Japan
      • Fukuoka, Japan
        • Fukuoka University Hospital
      • Kyoto, Japan
        • University Hospital, Kyoto Prefectural University of Medicine
      • Okayama, Japan
        • Okayama University Hospital
      • Osaka, Japan
        • Nippon Life Hospital
      • Osaka, Japan
        • Osaka Metropolitan University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan
        • Nagoya City University Hospital
      • Toyoake, Aichi-ken, Japan
        • Fujita Health University Hospital
    • Chiba
      • Kisarazu, Chiba, Japan
        • Kimitsu Chuo Hospital
      • Urayasu, Chiba, Japan
        • Juntendo University Urayasu Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Hospital of the University of Occupational and Environmental Health, Japan
    • Gunma
      • Isesaki, Gunma, Japan
        • Isesaki Municipal Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Kobe University Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Tokai University Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan
        • Mie University Hospital
    • Osaka
      • Hirakata, Osaka, Japan
        • Kansai Medical University Hospital
    • Saitama
      • Iruma, Saitama, Japan
        • Saitama Medical University Hospital
    • Tokyo
      • Chūō, Tokyo, Japan
        • St.Luke's International Hospital
      • Minato-ku, Tokyo, Japan
        • The Jikei University Hospital
      • Shinjuku-ku, Tokyo, Japan
        • Tokyo Medical University Hospital
      • tabashi City, Tokyo, Japan
        • Teikyo University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. A diagnosis of GPP or EP prior to the screening visit.
  2. Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

  1. Other forms of psoriasis.
  2. History of recent infection.
  3. Any prior exposure to TAK-279, or participation in any study that included a TYK2 inhibitor.

Other protocol defined inclusion/exclusion criteria apply.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TAK-279 for Generalized Pustular Psoriasis

Participants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52.
Geneesmiddel: TAK-279

Specified drug on specified days.
Experimenteel: TAK-279 for Erythrodermic Psoriasis

Participants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52.
Geneesmiddel: TAK-279

Specified drug on specified days.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater Than or Equal to (>=) 2-Point Decrease From Baseline at Week 16
Tijdsspanne: At Week 16

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1.
At Week 16
Percentage of Participants Who Achieved >=75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16
Tijdsspanne: At Week 16

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score were reported.
At Week 16

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Week 52
Tijdsspanne: At Week 52

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.
At Week 52
Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Both Weeks 16 and 52
Tijdsspanne: At both Weeks 16 and 52

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.
At both Weeks 16 and 52
Percentage of Participants Who Achieved an sPGA of Clear (0) at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Both Weeks 16 and 52
Tijdsspanne: At both Weeks 16 and 52

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.
At both Weeks 16 and 52
Percentage of Participants Who Achieved PASI-75 at Week 52
Tijdsspanne: At Week 52

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.
At Week 52
Percentage of Participants Who Achieved PASI-90 at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants Who Achieved PASI-100 at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants Who Achieved PASI-75 at Both Weeks 16 and 52
Tijdsspanne: At both Weeks 16 and 52

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.
At both Weeks 16 and 52
Percentage of Participants Who Achieved PASI-90 at Both Weeks 16 and 52
Tijdsspanne: At both Weeks 16 and 52

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produced a numeric score that ranged from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score are reported. The results will be disclosed during final posting.
At both Weeks 16 and 52
Percentage of Participants Who Achieved a Scalp-specific Physician's Global Assessment (ssPGA) of Absence of Disease (0) or Very Mild Disease (1) With a >=2-Point Decrease From Baseline at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicated worsening. The results will be disclosed during final posting.
At Weeks 16 and 52
Change From Baseline in ssPGA at Weeks 16 and 52
Tijdsspanne: Baseline, Weeks 16 and 52

ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicated worsening. The results will be disclosed during final posting.
Baseline, Weeks 16 and 52
Percentage of Participants Who Achieved a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

PGA is a 5-point scale and a score of 0 to 4 was assigned, based on the category that best described the severity of active psoriasis of the participant's hands and feet, where 0=clear and 4=severe. Higher scores indicated worsening of severity. It was evaluated for participants with the presence of active hand or foot psoriasis on Day 1. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants With a Baseline Dermatology Life Quality Index (DLQI) Score >=2 Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicated: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The results will be disclosed during final posting.
At Weeks 16 and 52
Change From Baseline in DLQI at Weeks 16 and 52
Tijdsspanne: Baseline, Weeks 16 and 52

The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicated: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). The results will be disclosed during final posting.
Baseline, Weeks 16 and 52
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Weeks 16 and 52 Among Participants With Nail Involvement at Baseline
Tijdsspanne: Baseline, Weeks 16 and 52

The NAPSI quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on the lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail was scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all fingernails evaluated and ranged from 0 to 80. Higher scores indicated more severe psoriasis. The results will be disclosed during final posting.
Baseline, Weeks 16 and 52
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Weeks 16 and 52
Tijdsspanne: Baseline, Weeks 16 and 52

Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting.
Baseline, Weeks 16 and 52
Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 16 and 52
Tijdsspanne: Baseline, Weeks 16 and 52

Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting.
Baseline, Weeks 16 and 52
Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a GPPGA of Clear (0) at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.
At Weeks 16 and 52
Percentage of Participants With Generalized Pustular Psoriasis Who Achieved >=75% Improvement From Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Weeks 16 and 52
Tijdsspanne: At Weeks 16 and 52

The GPPASI is a common endpoint in clinical studies of generalized pustular psoriasis (GPP) and is a skin-based scoring system. The GPPASI is a modified composite index and an adaptation of the PASI score. The induration component was substituted with a pustule component, with an overall score ranging from 0 (least severe) to 72 (most severe). Higher scores indicated more severe GPP. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The score for each body region was calculated as the product of the sum of severity scores and the corresponding BSA score for erythema, scaling, and pustulation, multiplied by a weighting factor for each body region. The total GPPASI score was determined as the sum of the individual scores from all body regions. The results will be disclosed during final posting.
At Weeks 16 and 52
Change From Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Weeks 16 and 52 for Participants With Generalized Pustular Psoriasis
Tijdsspanne: At Weeks 16 and 52

The Japanese Dermatological Association Severity Index (JDASI) assessed systemic symptoms based on laboratory changes. With the JDASI, the skin was evaluated using 3 criteria: (1) erythema area overall, (2) erythema area with pustules, and (3) oedema area. Scoring ranged from 3 to 0 (severe, moderate, mild, none), with a maximum of 9 points. For systemic involvement, pyrexia, white blood cell count, C-reactive protein (CRP), and serum albumin were assessed, with scores ranging from 2 to 0 and a maximum of 8 points. The total JDASI score for GPP was the sum of both categories and was categorized as severe (17-11 points), moderate (10-7 points), or mild (0-6 points). Higher scores indicated more severe GPP. The results will be disclosed during final posting.
At Weeks 16 and 52

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Takeda

Onderzoekers

  • Studie directeur: Study Director, Takeda

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 maart 2024

Primaire voltooiing (Werkelijk)

17 oktober 2025

Studie voltooiing (Werkelijk)

10 juli 2026

Studieregistratiedata

Eerst ingediend

15 maart 2024

Eerst ingediend dat voldeed aan de QC-criteria

15 maart 2024

Eerst geplaatst (Werkelijk)

21 maart 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

14 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TAK-279-PsO-3005
  • jRCT2031230714 (Register-ID: jRCT)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD-toegangscriteria voor delen

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren