Clinical trial • Phase II • Respiratory
XTMAB-16 for Pulmonary sarcoidosis
Phase II trial of XTMAB-16 for Pulmonary sarcoidosis. open-label. 70 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Pulmonary sarcoidosis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 11-09-2024
- First CTIS Authorization Date
- 15-01-2025
Trial design
open-label Phase II trial across 14 sites in Czechia, Italy, Spain and others.
- Open Label
- Yes
- Target Sample Size
- 70
Eligibility
Recruits 70 Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms are available in multiple languages (Czech, Italian, Spanish, Danish, Polish), including 'Scout' ICF documents. No further details on assent or consent handling for vulnerable participants are provided in the supplied JSON..
- Pregnancy Exclusion
- Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms are available in multiple languages (Czech, Italian, Spanish, Danish, Polish), including 'Scout' ICF documents. No further details on assent or consent handling for vulnerable participants are provided in the supplied JSON.
Inclusion criteria
- {"criterion_text":"- Completion of XTMAB-16-201 study: completion of Week 12 (Part A) or Week 24 (Part B) assessments.\n- Participants from XTMAB-16-201 Part A and Part B should be on a stable steroid dose for at least 2 weeks prior to informed consent/Day 1 of XTMAB-16-202 (Day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of XTMAB-16-201 ± 2 weeks)."}
Exclusion criteria
- {"criterion_text":"- Evidence of treatment-related AEs requiring treatment discontinuation per XTMAB-16-201 protocol observed in XTMAB-16-201 study.\n- Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition.\n- Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration","definition_or_measurement_approach":"As stated: rate of AEs (including SAEs and AESIs) measured throughout the study duration."}
Secondary endpoints
- {"endpoint_text":"- 1. Total corticosteroid dose: evaluation of accumulated dose over the first 12 weeks of the study o\tAverage daily dose o\tPercentage of time in study with dose ≤ 5 mg","definition_or_measurement_approach":"Accumulated corticosteroid dose over first 12 weeks; average daily dose; percentage of time in study with dose ≤ 5 mg (as stated)."}
- {"endpoint_text":"- 2. Proportion of participants with treatment failure and time to treatment failure, as defined in Section 5.4","definition_or_measurement_approach":"Proportion and time-to-event for treatment failure per protocol definition (Section 5.4)."}
- {"endpoint_text":"- 3. Change in quality-of-life measures from baseline to assessment timepoints throughout the study duration: o\tKing’s Sarcoidosis Questionnaire (KSQ) – Lung Module o KSQ – General Health Status Module o Leicester Cough Questionnaire (LCQ) o Steroid toxicity questionnaire (STQ)","definition_or_measurement_approach":"Change from baseline in KSQ (Lung and General Health modules), LCQ, and STQ at scheduled assessment timepoints (as stated)."}
- {"endpoint_text":"- 4. Change in pulmonary function tests from baseline to assessment timepoints throughout the study duration: o Forced vital capacity (FVC)","definition_or_measurement_approach":"Change from baseline in forced vital capacity (FVC) at scheduled assessment timepoints (as stated)."}
- {"endpoint_text":"- 5. Number and percentage of participants who test positive for XTMAB-16 anti-drug antibody (ADA)","definition_or_measurement_approach":"Number and percentage positive for anti-drug antibody to XTMAB-16 (as stated)."}
- {"endpoint_text":"- Number and percentage of participants who test positive for XTMAB-16 neutralizing antibodies (nAb)","definition_or_measurement_approach":"Number and percentage positive for neutralizing antibodies to XTMAB-16 (as stated)."}
- {"endpoint_text":"- 7. Absolute and percent change in biomarkers from baseline to assessment timepoints throughout the study duration: •\tAngiotensin converting enzyme (ACE) •\tInterleukin-6 (IL-6) •\tSoluble interleukin-2 receptor (sIL-2R) •\tSoluble tumor necrosis factor alpha (sTNFα) •C-reactive protein (CRP) •\tInterleukin-1b (IL-1b) •Calcitriol (Vitamin D1, 25)","definition_or_measurement_approach":"Absolute and percent change from baseline in listed serum biomarkers at scheduled assessment timepoints (as stated)."}
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 46
- Consent Approach
- Subject information and informed consent forms are provided per country (Czech, Italian, Spanish, Danish, Polish) including 'Scout' ICF versions and pregnancy data collection forms. The JSON lists country-specific SIS-ICF documents but does not provide further detail on the stepwise consent/assent process or languages beyond the document titles.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 24
Czechia
- Earliest CTIS Part Ii Submission Date
- 12-12-2024
- Latest Decision Or Authorization Date
- 16-01-2025
- Processing Time Days
- 35
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Pulmonology Clinic 1. LF UK and FTN
- Principal Investigator Name
- Jan Anton
- Principal Investigator Email
- jan.anton@ftn.cz
- Contact Person Name
- Jan Anton
- Contact Person Email
- jan.anton@ftn.cz
Italy
- Earliest CTIS Part Ii Submission Date
- 09-12-2024
- Latest Decision Or Authorization Date
- 20-01-2025
- Processing Time Days
- 42
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Pneumology
- Principal Investigator Name
- Fabrizio Luppi
- Principal Investigator Email
- fabrizio.luppi@unimib.it
- Contact Person Name
- Fabrizio Luppi
- Contact Person Email
- fabrizio.luppi@unimib.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Diseases of the Respiratory System and Lung Transplantation
- Principal Investigator Name
- Elena Bargagli
- Principal Investigator Email
- bargagli2@unisi.it
- Contact Person Name
- Elena Bargagli
- Contact Person Email
- bargagli2@unisi.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Specialistic Medicine – UO Pneumology
- Principal Investigator Name
- Claudia Ravaglia
- Principal Investigator Email
- claudia.ravaglia2@auslromagna.it
- Contact Person Name
- Claudia Ravaglia
- Contact Person Email
- claudia.ravaglia2@auslromagna.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-12-2024
- Latest Decision Or Authorization Date
- 15-01-2025
- Processing Time Days
- 33
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Pneumology
- Principal Investigator Name
- José Antonio Rodríguez Portal
- Principal Investigator Email
- jarportal@ecua.es
- Contact Person Name
- José Antonio Rodríguez Portal
- Contact Person Email
- jarportal@ecua.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Pneumology
- Principal Investigator Name
- Jacobo Sellares Torres
- Principal Investigator Email
- sellares@clinic.cat
- Contact Person Name
- Jacobo Sellares Torres
- Contact Person Email
- sellares@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pneumology
- Principal Investigator Name
- Ana Villar Gomez
- Principal Investigator Email
- avillar@vhebron.net
- Contact Person Name
- Ana Villar Gomez
- Contact Person Email
- avillar@vhebron.net
Denmark
- Earliest CTIS Part Ii Submission Date
- 18-12-2024
- Latest Decision Or Authorization Date
- 18-01-2025
- Processing Time Days
- 31
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Aalborg University Hospital
- Department Name
- Respiratory Research Unit
- Principal Investigator Name
- Ulla Møller Weinreich
- Principal Investigator Email
- ulw@dcm.aau.dk
- Contact Person Name
- Ulla Møller Weinreich
- Contact Person Email
- ulw@dcm.aau.dk
- Site Name
- Region Midtjylland
- Department Name
- Department of Respiratory Diseases and Allergy
- Principal Investigator Name
- Elisabeth Bendstrup
- Principal Investigator Email
- kabend@rm.dk
- Contact Person Name
- Elisabeth Bendstrup
- Contact Person Email
- kabend@rm.dk
- Site Name
- Sygehus Lillebaelt Vejle Sygehus
- Department Name
- Department of Regional Health Research
- Principal Investigator Name
- Ole Hilberg
- Principal Investigator Email
- ole.hilberg@rsyd.dk
- Contact Person Name
- Ole Hilberg
- Contact Person Email
- ole.hilberg@rsyd.dk
- Site Name
- Region Sjaelland
- Department Name
- Department of RespiratoryMedicine
- Principal Investigator Name
- Shailesh Kolekar
- Principal Investigator Email
- sbko@regionsjaelland.dk
- Contact Person Name
- Shailesh Kolekar
- Contact Person Email
- sbko@regionsjaelland.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Respiratory Medicine
- Principal Investigator Name
- Ingrid Titlestad
- Principal Investigator Email
- ingrid.titlestad@ouh.regionsyddanmark.dk
- Contact Person Name
- Ingrid Titlestad
- Contact Person Email
- ingrid.titlestad@ouh.regionsyddanmark.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 11-12-2024
- Latest Decision Or Authorization Date
- 21-01-2025
- Processing Time Days
- 41
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Centrum Medycyny Oddechowej Mroz Sp. j.
- Department Name
- Centrum Medycyny Oddechowej Mróz Spółka Jawna
- Principal Investigator Name
- Robert Mróz
- Principal Investigator Email
- informacjacmo@gmail.com
- Contact Person Name
- Robert Mróz
- Contact Person Email
- informacjacmo@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Oddział Kliniczny Pulmonologii i Alergologii
- Principal Investigator Name
- Wojciech Piotrowski
- Principal Investigator Email
- wojciech.piotrowski@umed.lodz.pl
- Contact Person Name
- Wojciech Piotrowski
- Contact Person Email
- wojciech.piotrowski@umed.lodz.pl
Sponsor
Primary sponsor
- Full Name
- Xentria Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Multiple sponsor duties (codes: 1,12,13,15 (Imaging),2,3,4,5,6) - listed as third party contact for CTIS (CTIS-Biotech@iconplc.com).
- Name
- Primevigilance Limited
- Responsibilities
- Pharmacovigilance / safety services (sponsorDuties code: 8).
- Name
- Frontage Laboratories Inc.
- Responsibilities
- Sample analyses and storage and laboratory analyses (sponsorDuties codes: 15 (Sample analyses and storage),4).
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,12,13,15 (Imaging),2,3,4,5,6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mms Holdings Inc.","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 15 (Sample analyses and storage),4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- XTMAB-16
- Active Substance
- XTMAB-16
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus=1 (as recorded in product dictionary)
- Orphan Designation
- Yes
- Maximum Dose
- 4.00 mg/kg (max daily); max total dose amount 160.00 mg/kg (as recorded)
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