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En fas 2 dosstudie av LY4100511 (tärning 853) på vuxna deltagare med måttlig till svår plackpsoriasis

24 juli 2026 uppdaterad av: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

En fas 2, multicenter, randomiserad, dubbelblind, placebokontrollerad, parallellgrupps-, dosintervallstudie av LY4100511 (DC-853) för behandling av vuxna deltagare med måttlig till svår plackpsoriasis

Huvudsyftet med denna studie är att bedöma säkerheten och effekten av LY4100511 hos vuxna deltagare med måttlig till svår plackpsoriasis.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

222

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35244
        • Cahaba Dermatology Skin Health Center
    • Arkansas
      • Bryant, Arkansas, Förenta staterna, 72022
        • Dermatology Trial Associates
    • California
      • Beverly Hills, California, Förenta staterna, 90212
        • Zenith Research, Inc.
      • Fountain Valley, California, Förenta staterna, 92708
        • First OC Dermatology Research Inc
      • Fremont, California, Förenta staterna, 94538-1614
        • Center for Dermatology Clinical Research
      • Los Angeles, California, Förenta staterna, 90045
        • Dermatology Research Associates
      • Santa Monica, California, Förenta staterna, 90404
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, Förenta staterna, 33134
        • Driven Research
      • Hialeah, Florida, Förenta staterna, 33012
        • Direct Helpers Research Center
      • Ocala, Florida, Förenta staterna, 34470
        • Renstar Medical Research
      • St. Petersburg, Florida, Förenta staterna, 33713-8012
        • GCP Global Clinical Professionals, LLC
      • Tampa, Florida, Förenta staterna, 33613
        • ForCare Clinical Research
    • Illinois
      • Skokie, Illinois, Förenta staterna, 60077-1049
        • Endeavor Clinical Trials Center - Dermatology - Skokie
    • Maryland
      • Rockville, Maryland, Förenta staterna, 20850
        • Lawrence J Green, M.D, LLC
    • Texas
      • Webster, Texas, Förenta staterna, 77598
        • Center for Clinical Studies, LTD.LLP
  • Japan
      • Tokyo, Japan
        • Igarashi Dermatological Clinic
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 450-0003
        • Nagoya City University Hospital
    • Hakkaido
      • Sapporo, Hakkaido, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-4101
        • Ohyama Dermatology Clinic
    • Osaka
      • Sakai-shi, Osaka, Japan, 593-8324
        • Kume Clinic
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tachikawa, Tokyo, Japan, 190-0023
        • Tachikawa Dermatology Clinic
    • Toyama
      • Takaoka, Toyama, Japan, 933-0871
        • Shirasaki dermatology clinic
  • Kanada
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1W 4V5
        • Interior Dermatology Centre - Probity - PPDS
      • Nanaimo, British Columbia, Kanada, V9T1W1
        • Skin Care West
    • Ontario
      • Barrie, Ontario, Kanada, L4M 7G1
        • Simcoderm Medical & Surgical Dermatology Centre
      • Hamilton, Ontario, Kanada, L8N 1Y2
        • Dermatrials Research Inc.
      • London, Ontario, Kanada, N6H 5L5
        • DermEffects - Probity - PPDS
      • London, Ontario, Kanada, N6A 5R9
        • Lovegrove Dermatology - Probity - PPDS
      • Markham, Ontario, Kanada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Kanada, L4Y 4C5
        • DermEdge Research
  • Polen
      • Katowice, Polen, 40-611
        • Centrum Medyczne Angelius Provita
      • Warsaw, Polen, 02-665
        • Centrum Medyczne Reuma Park NZOZ
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 50-566
        • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
      • Wroclaw, Lower Silesian Voivodeship, Polen, 50-381
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 00-710
        • Clinical Best Solutions
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Polen, 35-055
        • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-382
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Pomeranian Voivodeship, Polen, 81-537
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Polen, 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 70-332
        • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 90-436
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
  • Tjeckien
      • Pardubice, Tjeckien, 530 02
        • Pratia Pardubice a.s. - PRATIA - PPDS
      • Prague, Tjeckien, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tjeckien, 13000
        • Pratia Prague s.r.o. - PRATIA - PPDS
      • Prague, Tjeckien, 160 00
        • Kozni ambulance Fialova, s.r.o. - CRC - PPDS
    • Praha 10
      • Prague, Praha 10, Tjeckien, 10100
        • CLINTRIAL s.r.o.
  • Tyskland
      • Dresden, Tyskland, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU
      • Hamburg, Tyskland, 22391
        • MensingDerma Research GmbH
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Tyskland, 72076
        • Universitatsklinikum Tubingen
    • Bavaria
      • Augsburg, Bavaria, Tyskland, 86150
        • Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60590
        • Universitätsklinikum Frankfurt
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Tyskland, 48149
        • Universitätsklinikum Münster
  • Ungern
      • Gyöngyös, Ungern, 3200
        • Gyongyosi Bugat Pal Korhaz
      • Veszprém, Ungern, 8200
        • MedMare Bt
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Ungern, 4032
        • Debreceni Egyetem Klinikai Kozpont
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Ungern, 5000
        • Allergo-Derm Bakos Kft

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Klinisk diagnos av plackpsoriasis i 6 månader före randomiseringen av baslinjen dag 1
  • Måste ha ett kroppsmassaindex (BMI) på 18 till 40 kilogram/kvadratmeter (kg/m2) (inklusive).
  • Måste vara villig att avbryta topikala och/eller systemiska behandlingar för psoriasis före den första dosen av studieintervention.
  • Måste gå med på att undvika långvarig exponering för solen och att avstå från att använda solariebås, sollampor och andra källor för ultraviolett ljus under studien

Uteslutningskriterier:

  • Har haft en kliniskt signifikant uppblossning av psoriasis under de 12 veckorna före baslinjen, enligt bedömningen av utredaren.
  • Har en historia av erytrodermisk psoriasis, generaliserad eller lokaliserad pustulös psoriasis, övervägande guttat psoriasis, eller läkemedelsinducerad eller läkemedelsförvärrad psoriasis.
  • Har någon känd eller misstänkt diagnos av andra inflammatoriska tillstånd än psoriasis och psoriasisartrit, inklusive men inte begränsat till reumatoid artrit, sarkoidos, IBD (Crohns sjukdom eller ulcerös kolit) eller systemisk lupus erythematosus.
  • Har en diagnos av psoriasisartrit som kräver, eller får för närvarande, systemisk immunsuppressiv medicinsk behandling (inklusive kortikosteroider, immunsuppressiva medel och biologiska läkemedel).
  • Har en aktuell eller nyligen akut aktiv infektion. Deltagaren får inte ha några symtom eller tecken på bekräftad eller misstänkt infektion och måste ha genomfört lämplig anti-infektionsbehandling i minst 30 dagar före screening och fram till randomisering/baslinje.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: LY4100511 200 mg BID
Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.
Läkemedel: LY4100511
Administreras oralt
Experimentell: LY4100511 400 mg BID
Participants received LY4100511 400 mg administered orally BID for 12 weeks.
Läkemedel: LY4100511
Administreras oralt
Experimentell: LY4100511 800 mg QD
Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.
Läkemedel: LY4100511
Administreras oralt
Placebo-jämförare: Placebo BID
Participants received placebo administered orally BID for 12 weeks.
Läkemedel: Placebo
Administreras oralt

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
Tidsram: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)
Tidsram: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
Tidsram: Week 12

Percentage of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement from baseline at Week 12. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe):

  • 0 = Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may occur
  • 1 = Almost clear: Normal to pink lesions; no thickening; no or minimal focal scaling
  • 2 = Mild: Pink to light red color; slight thickening; mainly fine scaling
  • 3 = Moderate: Dull bright red erythema; moderate thickening; moderate scaling
  • 4 = Severe: Bright to deep red; severe thickening with hard edges; coarse scaling covering most or all lesions
Week 12
Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12
Tidsram: Week 12
Percentage of participants achieving ≥50% reduction from baseline in PASI-50 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Tidsram: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
Tidsram: Week 12
Percentage of participants achieving ≥90% reduction from baseline in PASI-90 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12
Tidsram: Week 12
Percentage of participants achieving ≥100% reduction from baseline in PASI-100 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Change From Baseline in PASI Score at Week 12
Tidsram: Baseline, Week 12

Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.

The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Baseline, Week 12
Percent Change From Baseline in PASI Score at Week 12
Tidsram: Baseline, Week 12

Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.

The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Baseline, Week 12
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12
Tidsram: Baseline, Week 12

Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.

BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Baseline, Week 12
Percent Change From Baseline in the Percentage of BSA Affected at Week 12
Tidsram: Baseline, Week 12

Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.

BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Baseline, Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
Tidsram: Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.
Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511
Tidsram: Predose at Day 8, 15, 29, 57 and 85
Ctrough,ss of LY4100511
Predose at Day 8, 15, 29, 57 and 85
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511
Tidsram: Baseline up to Week 12

The number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of LY4100511.

A TEAE is defined as an AE that occurs during or after the first study drug administration and up to and including the follow-up visit.

A serious adverse event (SAE) is any untoward medical occurrence at any dose that:

  • Results in death
  • Is life-threatening (risk of death at the time of the event)
  • Requires inpatient hospitalization or prolongation of existing hospitalization (excluding elective admission for a stable pre-existing condition)
  • Results in persistent disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other medically important event that may jeopardize the participant or require intervention to prevent the above outcomes
Baseline up to Week 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Utredare

  • Studierektor: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 oktober 2024

Primärt slutförande (Faktisk)

24 juli 2025

Avslutad studie (Faktisk)

4 september 2025

Studieregistreringsdatum

Först inskickad

16 september 2024

Först inskickad som uppfyllde QC-kriterierna

16 september 2024

Första postat (Faktisk)

19 september 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18845
  • J5C-MC-FOAB (Annan identifierare: DCE853201)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Anonymiserad individuell patientnivådata kommer att tillhandahållas i en säker åtkomstmiljö efter godkännande av ett forskningsförslag och ett undertecknat datadelningsavtal.

Tidsram för IPD-delning

Data finns tillgängliga 6 månader efter den primära publiceringen och godkännandet av indikationen som studerats i USA och Europeiska unionen (EU), beroende på vilket som inträffar senare. Data kommer att vara tillgängliga på obestämd tid för begäran.

Kriterier för IPD Sharing Access

forskningsförslag måste godkännas av en oberoende granskningspanel och forskare måste underteckna ett datadelningsavtal.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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