Clinical trial • Phase IV • Immunology

TULISOKIBART for Systemic sclerosis associated with interstitial lung disease

Phase IV trial of TULISOKIBART for Systemic sclerosis associated with interstitial lung disease.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic sclerosis associated with interstitial lung disease
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
15-07-2024

Trial design

Randomised, placebo: 0.9% normal saline solution matched to imp and administered iv on the same schedule as active (placebo iv at day 1/week 0, week 2, then every 4 weeks until week 46).-controlled Phase IV trial in France, Germany, Belgium and others.

Randomised
Yes
Comparator
Placebo: 0.9% normal saline solution matched to IMP and administered IV on the same schedule as active (placebo IV at Day 1/Week 0, Week 2, then every 4 weeks until Week 46).
Biomarker Stratified
True; biomarkers/strata: anti-topoisomerase antibody (anti-Scl-70) (+/-) and CDx status (+/-)
Target Sample Size
152
Trial Duration For Participant
434

Stratification factors

  • Presence of anti-topoisomerase antibody (anti-Scl-70) (+/-)
  • CDx status (+/-)

Eligibility

Recruits 152 The trial flags 'isVulnerablePopulationSelected': true. Participants must be able to provide written informed consent (inclusion criterion: "Able to provide written informed consent"). Specific informed consent documents are provided for different participant types (Main ICF, Pregnant Participant ICF, Pregnant Partner ICF, Pharmacogenomics ICF). No procedures for assent of minors are provided (study includes adults ≥18)..

Pregnancy Exclusion
10.A female subject is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP) OR • Is a WOCBP and: - Uses an acceptable contraceptive method, or is abstinent from penilevaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis),from at least 4 weeks prior to Day 1/Week 0, during the intervention period, and for at least 14 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. For any background medications, the local label should be followed for contraception. - Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a WOCBP with an early undetected pregnancy
Vulnerable Population
The trial flags 'isVulnerablePopulationSelected': true. Participants must be able to provide written informed consent (inclusion criterion: "Able to provide written informed consent"). Specific informed consent documents are provided for different participant types (Main ICF, Pregnant Participant ICF, Pregnant Partner ICF, Pharmacogenomics ICF). No procedures for assent of minors are provided (study includes adults ≥18).

Inclusion criteria

  • {"criterion_text":"- 1.Male or female ≥ 18 years of age.\n- 2.Subjects must meet the 2013 ACR/EULAR definition of SSc. \n- 3.Subjects must have had SSc onset (defined by first non-Raynaud symptom) ≤ 5 years (60 months) prior to screening.\n- 4.Subjects must have diffuse cutaneous scleroderma defined as any level of skin thickening proximal to the elbows and knees exclusive of the face and neck. Total mRSS must be 10 to 35 units, inclusive.\n- 5.Subjects must have SSc-related ILD of fibrotic disease in lung confirmed by HRCT ≥ 10% extent of involvement, assessed by central reading.\n- 6.FVC ≥ 45% of predicted normal.\n- 7.Diffusing capacity of lung for carbon monoxide (DLCO) ≥ 45% of predicted normal (corrected for hemoglobin [Hgb]).\n- 8.Meet at least one of the following criteria: a. C-reactive protein (CRP) > upper limit of normal (ULN) b. Erythrocyte sedimentation rate (ESR) > 28 mm/hr c. Positive for anti-topoisomerase (anti-Scl-70) antibody\n- 9.Background therapy is not required, but subjects receiving background therapy must meet drug stabilization requirements, as applicable: a.Either mycophenolate mofetil (not to exceed 3 g/day) or oral or subcutaneous methotrexate (not to exceed 25 mg/week) or azathioprine (not to exceed 150 mg/day) for ≥ 4 months prior to randomization (not more than 1 therapy) and on a stable dose for 4 weeks prior to randomization b.Subjects who have been on nintedanib for ≥ 6 months (and stable dose for at least 4 weeks) prior to randomization may enter the study provided that there has not been any improvement in FVC (% and absolute) from prior to the initiation of nintedanib therapy c.A stable dose of oral corticosteroids (≤ 10 mg/day prednisone equivalent) for 2 weeks prior to randomization. Inhaled and topical corticosteroids are permitted.\n- 10.A female subject is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP) OR • Is a WOCBP and: - Uses an acceptable contraceptive method, or is abstinent from penilevaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis),from at least 4 weeks prior to Day 1/Week 0, during the intervention period, and for at least 14 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. For any background medications, the local label should be followed for contraception. - Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a WOCBP with an early undetected pregnancy\n- 11.Able to provide written informed consent and understand and comply with the requirements of the study."}

Exclusion criteria

  • {"criterion_text":"- 1.Subjects with a history of cancer within the last 5 years (other than (other than non-melanoma skin cell cancers cured by local resection or cervical carcinoma in situ).Existing non-melanoma skin cell cancers must be removed prior to enrollment. Subjects with carcinoma in situ or localized cervical cancer, treated with definitive surgical intervention, are allowed.\n- 2. Subject has active TB or meets TB exclusionary parameters\n- 3.Subjects with chronic or recurrent infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis).\n- 4. Subjects with any active infections (excluding fungal infections of nail beds) including, but not limited to, those that require IV or IM antimicrobial treatment 4 weeks or oral antimicrobial treatment 2 weeks prior to randomization.\n- 5.Subjects known to be infected with HBV, HCV, or HIV • Participants with positive HBsAg are excluded from the study. Participants with negative HBsAg and positive HBcAb must have further testing for HBV-DNA. Participants with HBV-DNA ≥LLOQ are not eligible for the study. Participants with HBV-DNA"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1.The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values.","definition_or_measurement_approach":"Proportion of subjects reporting AEs/SAEs/AEs leading to discontinuation collected throughout the study; marked laboratory abnormalities identified via clinical laboratory testing during scheduled visits."}
  • {"endpoint_text":"- 2.To compare the annual rate of change from Baseline in FVC in mL of MK-7240/PRA023 vs. placebo over 50 weeks","definition_or_measurement_approach":"Annual rate of change in forced vital capacity (FVC) measured in mL from baseline to Week 50 (spirometry per protocol); comparison between active and placebo over 50 weeks."}

Secondary endpoints

  • {"endpoint_text":"- 1.To compare the change from Baseline in FVC in mL of MK-7240/PRA023 vs. placebo at Week 50.","definition_or_measurement_approach":"Change from baseline in FVC (mL) at Week 50 measured by spirometry."}
  • {"endpoint_text":"- 2.To compare the change from Baseline in HRCT QILD-WL of MK-7240/PRA023 vs. placebo at Week 50","definition_or_measurement_approach":"Change from baseline in quantitative HRCT whole-lung QILD-WL score at Week 50 assessed by central HRCT reading and quantitative image analysis."}
  • {"endpoint_text":"- 3.To compare proportion of subjects with an improvement in the revised CRISS score of MK-7240/PRA023 vs. placebo at Week 50.","definition_or_measurement_approach":"Proportion of subjects with improvement in revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 50 using the CRISS scoring algorithm."}
  • {"endpoint_text":"- 4.To assess the change from Baseline in HAQ-DI of MK-7240/PRA023 vs. placebo at Week 50","definition_or_measurement_approach":"Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50 using the HAQ-DI instrument."}
  • {"endpoint_text":"- 5.To assess the change from Baseline in L-PF patient-reported quality of life (QoL) outcome of MK-7240/PRA023 vs. placebo at Week 50","definition_or_measurement_approach":"Change from baseline in Living with Pulmonary Fibrosis (L-PF) patient-reported QoL outcome at Week 50 using the L-PF questionnaire."}

Recruitment

Digital Remote Recruitment
True; recruitment materials include web-text templates and online patient brochures (study web-text documents present) intended for online study pages and digital patient outreach.
Planned Sample Size
152
Recruitment Window Months
84
Consent Approach
Written informed consent required from each participant (inclusion criterion: able to provide written informed consent). Country/language-specific ICFs provided (Main ICF and ancillary ICFs available in German, Dutch, English, French, Spanish, Italian, Polish, Hungarian and other local languages as per submitted ICF documents). Separate informed consent documents exist for pregnant participants and pregnant partners; no assent procedures for minors (study population ≥18 years).

Methods

  • Referral letters to clinicians (referral-letter documents present) — channel: clinician referral; materials available for Germany, Spain, Hungary, Italy, Belgium, Poland (country-specific referral letters/brochures).
  • Patient brochures / trifold patient brochure — channel: printed brochures distributed at sites and clinics; multilingual templates available (BE, DE, EN, FR, NL, etc.).
  • Web text / online study pages — channel: web-text templates and study web-text documents for multiple countries (DE, BE, NL, ES, etc.) providing PI contact details and study information.
  • Referral brochures and PI contact details on printed materials — channel: local site contact details included on recruitment materials to direct potential participants to site investigators.
  • Recruitment and Informed Consent Procedure documents for specific Member States (country-specific recruitment procedures and documents submitted for publication).

Geography

Total Number Of Sites
36
Total Number Of Participants
103

France

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
6
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Rhumatologie A
Principal Investigator Name
Yannick ALLANORE
Principal Investigator Email
yannick.allanore@cch.aphp.fr
Contact Person Name
Yannick ALLANORE
Contact Person Email
yannick.allanore@cch.aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Rhumatologie A
Principal Investigator Name
Marie-Elise TRUCHETET
Principal Investigator Email
marie-elise.truchetet@chu-bordeaux.fr
Contact Person Name
Marie-Elise TRUCHETET
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Médecine Interne
Principal Investigator Name
Eric HACHULLA
Principal Investigator Email
eric.hachulla@chru-lille.fr
Contact Person Name
Eric HACHULLA
Contact Person Email
eric.hachulla@chru-lille.fr

Germany

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
6
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Kerckhoff-Klinik GmbH
Department Name
Justus-Liebig-Universität Gießen Campus Kerckhoff
Principal Investigator Name
Ulf Müller-Ladner
Principal Investigator Email
u.mueller-ladner@kerckhoff-klinik.de
Contact Person Name
Ulf Müller-Ladner
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Rheumatologie und Klinische Immunologie, Therapiestudienzentrum / Studienambulanz
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
Stephanie.Finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin II - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Principal Investigator Name
Torsten Kubacki
Principal Investigator Email
torsten.kubacki@uk-koeln.de
Contact Person Name
Torsten Kubacki
Contact Person Email
torsten.kubacki@uk-koeln.de
Site Name
Prof. Dr. med. Gunther Neeck MVZ GmbH
Department Name
Rheumazentrum
Principal Investigator Name
Gunther Neeck
Principal Investigator Email
gunther.neeck@biomedro.de
Contact Person Name
Eric HACHULLA
Contact Person Email
gunther.neeck@biomedro.de

Belgium

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
6
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Rheumatology
Principal Investigator Name
Vanessa Smith
Principal Investigator Email
vanessa.smith@ugent.be
Contact Person Name
Vanessa Smith
Contact Person Email
vanessa.smith@ugent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Rheumatology
Principal Investigator Name
Béatrice André
Principal Investigator Email
bandre@chuliege.be
Contact Person Name
Béatrice André
Contact Person Email
bandre@chuliege.be

Hungary

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
6
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
University Of Pecs
Department Name
Reumatologiai es Immunologiai Klinika
Principal Investigator Name
Gabor Kumanovics
Principal Investigator Email
kumanovics.gabor@pte.hu
Contact Person Name
Gabor Kumanovics
Contact Person Email
kumanovics.gabor@pte.hu
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Belgyogyaszat-Immunologiai Ambulancia
Principal Investigator Name
Janos Kadar
Principal Investigator Email
drkadarj@t-online.hu
Contact Person Name
Janos Kadar
Contact Person Email
drkadarj@t-online.hu
Site Name
University Of Debrecen
Department Name
Department of Rheumatology
Principal Investigator Name
Gabriella Szűcs
Principal Investigator Email
szucsgpafi@gmail.com
Contact Person Name
Gabriella Szűcs
Contact Person Email
szucsgpafi@gmail.com
Site Name
Budai Irgalmasrendi Korhaz Nonprofit Kft.
Department Name
Reumatologiai Centrum
Principal Investigator Name
Dóra Sárvári
Principal Investigator Email
sarvaridorastudy@gmail.com
Contact Person Name
Dóra Sárvári
Contact Person Email
sarvaridorastudy@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
11
Number Of Sites
8
Number Of Participants
13

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UO Scleroderma e SS Malattie Autoimmuni Sistemiche
Principal Investigator Name
Lorenzo Beretta
Principal Investigator Email
lorenzo.beretta@policlinico.mi.it
Contact Person Name
Lorenzo Beretta
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Immunologia, Reumatologia, Allergia e Malattie Rare
Principal Investigator Name
Marco Matucci Cerinic
Principal Investigator Email
matuccicerinic.marco@hsr.it
Contact Person Name
Marco Matucci Cerinic
Contact Person Email
matuccicerinic.marco@hsr.it
Site Name
Careggi University Hospital
Department Name
SOD di Reumatologia
Principal Investigator Name
Silvia Bellando Randone
Principal Investigator Email
silvia.bellandrorandone@unifi.it
Contact Person Name
Silvia Bellando Randone
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Reumatologia
Principal Investigator Name
Veronica Codullo
Principal Investigator Email
v.codullo@smatteo.pv.it
Contact Person Name
Veronica Codullo
Contact Person Email
v.codullo@smatteo.pv.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SC Reumatologia
Principal Investigator Name
Enrico Fusaro
Principal Investigator Email
reumatologia@cittadellasalute.to.it
Contact Person Name
Enrico Fusaro
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clicnica di Reumatologia - DIMI (Dipartimento di medicina interna e specialità mediche)
Principal Investigator Name
Maurizio Cutolo
Principal Investigator Email
mcutolo@unige.it
Contact Person Name
Maurizio Cutolo
Contact Person Email
mcutolo@unige.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Medicina Interna e Specialità Mediche – Reumatologia
Principal Investigator Name
Valeria Riccieri
Principal Investigator Email
valeria.riccieri@uniroma1.it
Contact Person Name
Valeria Riccieri
Contact Person Email
valeria.riccieri@uniroma1.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
SC Reumatologia
Principal Investigator Name
Gianluigi Bajocchi
Principal Investigator Email
baiocchi.gianluigi@asmn.re.it
Contact Person Name
Gianluigi Bajocchi
Contact Person Email
baiocchi.gianluigi@asmn.re.it

Spain

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
13
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medicina Interna
Principal Investigator Name
Alfredo Guillén del Castillo
Principal Investigator Email
alfredo.guillen@vallhebron.cat
Contact Person Name
Alfredo Guillén del Castillo
Contact Person Email
alfredo.guillen@vallhebron.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Reumatología
Principal Investigator Name
Antonio Fernández Nebro
Contact Person Name
Antonio Fernández Nebro
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Reumatología
Principal Investigator Name
Ivan Castellví Barranco
Principal Investigator Email
icastellvi@santpau.cat
Contact Person Name
Ivan Castellví Barranco
Contact Person Email
icastellvi@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medicina Interna
Principal Investigator Name
Andres González García
Principal Investigator Email
andres.gonzalez@salud.madrid.org
Contact Person Name
Andres González García
Site Name
Hospital Universitario 12 De Octubre
Department Name
Reumatologia
Principal Investigator Name
Patricia E. Carreira
Principal Investigator Email
carreira@h12o.es
Contact Person Name
Patricia E. Carreira
Contact Person Email
carreira@h12o.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Medicina Interna
Principal Investigator Name
Miguel Arias Guillen
Principal Investigator Email
mag@crit-lab.org
Contact Person Name
Miguel Arias Guillen
Contact Person Email
mag@crit-lab.org
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Reumatología
Principal Investigator Name
Juan Jose Alegre Sancho
Principal Investigator Email
alegre_juasan@gva.es
Contact Person Name
Juan Jose Alegre Sancho
Contact Person Email
alegre_juasan@gva.es

Netherlands

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
4
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Rheumatology
Principal Investigator Name
Madelon Vonk
Principal Investigator Email
Madelon.Vonk@radboudumc.nl
Contact Person Name
Madelon Vonk
Contact Person Email
Madelon.Vonk@radboudumc.nl

Poland

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
04-08-2024
Processing Time Days
24
Number Of Sites
7
Number Of Participants
53

Sites

Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Brygida Kwiatkowska
Principal Investigator Email
brygida.kwiatkowska@spartanska.pl
Contact Person Name
Brygida Kwiatkowska
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Reumatologii i Chorób Wewnętrznych
Principal Investigator Name
Otylia Kowal-Bielecka
Principal Investigator Email
otylia.bielecka@gmail.com
Contact Person Name
Otylia Kowal-Bielecka
Contact Person Email
otylia.bielecka@gmail.com
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Department Name
Rheumatology
Principal Investigator Name
Agata Wytyk-Nowak
Principal Investigator Email
wytyk@twojaprzychodnia.com
Contact Person Name
Agata Wytyk-Nowak
Contact Person Email
wytyk@twojaprzychodnia.com
Site Name
Centrum Medyczne Oporow
Department Name
Rheumatology
Principal Investigator Name
Maria Misterska-Skrora
Principal Investigator Email
maria.misterska-skora@cmoporow.com
Contact Person Name
Maria Misterska-Skrora
Site Name
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
Department Name
Oddział Reumatologii i Rehabilitacji
Principal Investigator Name
Aleksandra Zoń-Giebel
Principal Investigator Email
azongiebel@gmail.com
Contact Person Name
Aleksandra Zoń-Giebel
Contact Person Email
azongiebel@gmail.com
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Principal Investigator Name
Anna Zubrzycka-Sienkiewicz
Principal Investigator Email
annazub1@wp.pl
Contact Person Name
Anna Zubrzycka-Sienkiewicz
Contact Person Email
annazub1@wp.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Principal Investigator Name
Iwona Dankiewicz-Fares
Principal Investigator Email
iwonafares@wp.pl
Contact Person Name
Iwona Dankiewicz-Fares
Contact Person Email
iwonafares@wp.pl

Sponsor

Primary sponsor

Full Name
Prometheus Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Sponsor duties codes: 1,10,2,4,5,6,7,8
Name
Syneos Health Clinique Inc.
Responsibilities
PK, Neutralizing antibody and Immunogenicity sample testing
Name
Voiant LLC
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc
Name
Q2 Solutions LLC
Responsibilities
TL1A biomarkers testing
Name
Clinical Ink Inc.
Responsibilities
eCOA (questionnaries)
Name
Vitalograph
Responsibilities
Spirometry and DLCO (respiratory assessments)
Name
Suvoda LLC
Responsibilities
Sponsor duties code: 3
Name
PPD Central Lab
Responsibilities
Sponsor duties code: 4

Third parties

  • {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"TL1A biomarkers testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"PK, Neutralizing antibody and Immunogenicity sample testing","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eCOA (questionnaries)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vitalograph","duties_or_roles":"Spirometry and DLCO (respiratory assessments)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Sponsor duties codes: 1,10,2,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Central Lab","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Health care"}

Investigational products

Investigational Product Name
tulisokibart (MK-7240 / PRA023)
Active Substance
TULISOKIBART
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Starting Dose
1000 mg IV on Day 1/Week 0
Dose Levels
1000 mg (Week 0 Day 1) then 500 mg (Week 2 and every 4 weeks thereafter)
Frequency
1000 mg on Week 0/Day 1, then 500 mg IV at Week 2, then every 4 weeks until Week 46
Maximum Dose
1000 mg
Investigational Product Name
Placebo (0.9% normal saline)
Modality
Other
Routes Of Administration
Intravenous
Route
Intravenous
Starting Dose
Placebo matched to active dosing schedule (IV)
Dose Levels
Placebo administered matching active schedule (Day 1: matching volume, Week 2: matching volume, then Q4W)
Frequency
Day 1/Week 0; Week 2; then every 4 weeks until Week 46

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