Clinical trial • Phase IV • Respiratory
HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST CRLF2 for Severe asthma
Phase IV trial of HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST CRLF2 for Severe asthma.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Severe asthma
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 15-04-2025
- First CTIS Authorization Date
- 07-08-2025
Trial design
Randomised, matching placebo (veritikug), matching solution for subcutaneous injection with no active treatment. dosing approach: all participants administered 2 sc injections every 12 weeks (q12w); arm descriptions: verekitug (upb-101) - dose 1: delivered as 0.5 ml of the formulated solution for sc injection and 2.0 ml of placebo delivered subcutaneously in two separate injections; verekitug (upb-101) - dose 2: delivered as 2.0 ml of the formulated solution for sc injection and 0.5 ml of placebo delivered subcutaneously in two separate injections.-controlled Phase IV trial in Czechia, Spain, Poland and others.
- Randomised
- Yes
- Comparator
- Matching placebo (Veritikug), matching solution for subcutaneous injection with no active treatment. Dosing approach: all participants administered 2 SC injections every 12 weeks (Q12W); arm descriptions: Verekitug (UPB-101) - dose 1: delivered as 0.5 mL of the formulated solution for SC injection and 2.0 mL of placebo delivered subcutaneously in two separate injections; Verekitug (UPB-101) - dose 2: delivered as 2.0 mL of the formulated solution for SC injection and 0.5 mL of placebo delivered subcutaneously in two separate injections.
- Target Sample Size
- 312
- Trial Duration For Participant
- 532
Eligibility
Recruits 312 The trial record indicates vulnerable population selection (isVulnerablePopulationSelected: true). Consent must be given by the participant: principal inclusion criterion states "Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study." Participants judged incapable of giving informed consent are excluded (see exclusion criterion 6). ICF and related subject information documents are provided and available in multiple language versions (English, Spanish, Bulgarian, Polish, Czech, Italian) and include specific materials (e.g. Pregnant Partner notices). No assent procedures are described (adult participants only)..
- Pregnancy Exclusion
- 4. Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
- Vulnerable Population
- The trial record indicates vulnerable population selection (isVulnerablePopulationSelected: true). Consent must be given by the participant: principal inclusion criterion states "Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study." Participants judged incapable of giving informed consent are excluded (see exclusion criterion 6). ICF and related subject information documents are provided and available in multiple language versions (English, Spanish, Bulgarian, Polish, Czech, Italian) and include specific materials (e.g. Pregnant Partner notices). No assent procedures are described (adult participants only).
Inclusion criteria
- {"criterion_text":"- 1. Completion of the VALIANT study per protocol. Participants must have not met VALIANT discontinuation criteria and have attended the VALIANT EOS visit.\n- 2. Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study.\n- 3. Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}
Exclusion criteria
- {"criterion_text":"- 1.\tAbnormal medical history, physical finding, or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant’s safety.\n- 2.\tAny clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant’s safety.\n- 3.\tParticipant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction).\n- 4.\tPregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.\n- 5.\tParticipants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.\n- 6.\tParticipant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the Investigator or has any disorder that may compromise their ability to give informed consent."}
Endpoints
Primary endpoints
- {"endpoint_text":"- To check if verekitug is safe, participants will be monitored for any side effects from the time the participant agrees to join the study until the participant completes the study. Participants will also have physical examinations, clinical laboratory assessments, vital sign measurements, and ECGs from the first LTE study visit, or last VALIANT study visit, until the participant completes the LTE study.","definition_or_measurement_approach":"Monitoring for adverse events from consent until study completion; physical examinations, clinical laboratory assessments, vital signs and ECGs performed from first LTE visit (or last VALIANT visit) until study completion."}
Secondary endpoints
- {"endpoint_text":"- To check the effects of verekitug, the number of severe asthma flare-ups or attacks that require treatment with steroids over 60 weeks of treatment will be recorded.","definition_or_measurement_approach":"Count of severe asthma exacerbations requiring corticosteroid treatment recorded over 60 weeks of treatment."}
- {"endpoint_text":"- The change in the following from the start of the LTE study up to Week 60 will be recorded: how much air the participant can forcefully exhale in 1 second; how much nitric oxide is in the exhaled air as a measure of airway inflammation; and how well the participant’s asthma is being managed via a scored questionnaire about asthma symptoms and treatment.","definition_or_measurement_approach":"Change from baseline to Week 60 in FEV1 (forced expiratory volume in 1 second), fractional exhaled nitric oxide (FeNO), and asthma control as measured by a scored questionnaire."}
- {"endpoint_text":"- The amount of verekitug in the blood will be measured at each visit to see how the body processes verekitug. The blood will also be checked for antibodies against verekitug during the LTE study (from the first to last visit) to check for an immune response.","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentration of verekitug at each visit. Immunogenicity: assay for anti-drug antibodies measured from first to last visit."}
Recruitment
- Planned Sample Size
- 312
- Recruitment Window Months
- 22
- Consent Approach
- Informed consent must be signed and dated by the participant and a copy provided (IRB/IEC-approved written ICF). ICFs and subject information are provided in multiple language versions (document inventory includes English, Spanish, Bulgarian, Polish, Czech, Italian). Specific information materials include main ICF, pregnancy-related ICFs and privacy notices. Participants judged unable to provide informed consent are excluded. No assent procedures are described (adult participants only).
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 123
Czechia
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 176
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Ustav klinicke imunologie a alergologie
- Principal Investigator Name
- Zita Chovancova
- Principal Investigator Email
- zita.chovancova@fnusa.cz
- Contact Person Name
- Zita Chovancova
- Contact Person Email
- zita.chovancova@fnusa.cz
- Site Name
- Plicni Stredisko Teplice s.r.o.
- Department Name
- Plicni stredisko Teplice s.r.o.
- Principal Investigator Name
- Stanislav Holub
- Principal Investigator Email
- stanislavholub@seznam.cz
- Contact Person Name
- Stanislav Holub
- Contact Person Email
- stanislavholub@seznam.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 22-07-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 185
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Giromed Institute S.L.P.
- Department Name
- Pneumology
- Principal Investigator Name
- Juan Roldan
- Principal Investigator Email
- Juan.roldan@giromedistitute.com
- Contact Person Name
- Juan Roldan
- Contact Person Email
- Juan.roldan@giromedistitute.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Pulmonology
- Principal Investigator Name
- Luis Puente Maestu
- Principal Investigator Email
- luis.puente@salud.madrid.org
- Contact Person Name
- Luis Puente Maestu
- Contact Person Email
- luis.puente@salud.madrid.org
Poland
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 185
- Number Of Sites
- 12
- Number Of Participants
- 32
Sites
- Site Name
- Atopia NZOZ
- Principal Investigator Name
- Grazyna Jasieniak-Pinis
- Principal Investigator Email
- atopia@atopia.pl
- Contact Person Name
- Grazyna Jasieniak-Pinis
- Contact Person Email
- atopia@atopia.pl
- Site Name
- Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
- Principal Investigator Name
- Piotr Napora
- Principal Investigator Email
- napora.piotr@cbk.wroc.pl
- Contact Person Name
- Piotr Napora
- Contact Person Email
- napora.piotr@cbk.wroc.pl
- Site Name
- Lekarze Specjalisci J. Malolepszy I Partnerzy
- Principal Investigator Name
- Krzysztof Wytrychowski
- Principal Investigator Email
- anhw@op.pl
- Contact Person Name
- Krzysztof Wytrychowski
- Contact Person Email
- anhw@op.pl
- Site Name
- EMED Centrum Usług Medycznych Ewa Śmiałek
- Principal Investigator Name
- Slawomir Tokarski
- Principal Investigator Email
- stokarski@emed-cum.pl
- Contact Person Name
- Slawomir Tokarski
- Contact Person Email
- stokarski@emed-cum.pl
- Site Name
- Alergo Med Osrodek Badan Klinicznych Sp. z o.o.
- Principal Investigator Name
- Bernadetta Majorek Olechowska
- Principal Investigator Email
- bernadettaolechowska@gmail.com
- Contact Person Name
- Bernadetta Majorek Olechowska
- Contact Person Email
- bernadettaolechowska@gmail.com
- Site Name
- Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
- Department Name
- Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
- Principal Investigator Name
- Anna Olech-Cudzik
- Principal Investigator Email
- annacudzik@cudmed.pl
- Contact Person Name
- Anna Olech-Cudzik
- Contact Person Email
- annacudzik@cudmed.pl
- Site Name
- Malopolskie Centrum Alergologii Sp. z o.o.
- Principal Investigator Name
- Malgorzata Bederska
- Principal Investigator Email
- malgorzatabederska@gmail.com
- Contact Person Name
- Malgorzata Bederska
- Contact Person Email
- malgorzatabederska@gmail.com
- Site Name
- ALL-MED SPECJALISTYCZNA OPIEKA MEDYCZNA. MEDYCZNY INSTYTUT BADAWCZY
- Principal Investigator Name
- Marek Jutel
- Principal Investigator Email
- marek.jutel@all-med.wroclaw.pl
- Contact Person Name
- Marek Jutel
- Contact Person Email
- marek.jutel@all-med.wroclaw.pl
- Site Name
- Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
- Principal Investigator Name
- Malgorzata Pawlukiewicz
- Principal Investigator Email
- mpawlu@onet.eu
- Contact Person Name
- Malgorzata Pawlukiewicz
- Contact Person Email
- mpawlu@onet.eu
- Site Name
- Centrum Medycyny Oddechowej Mroz Sp. j.
- Principal Investigator Name
- Robert Mroz
- Principal Investigator Email
- robmmroz@gmail.com
- Contact Person Name
- Robert Mroz
- Contact Person Email
- robmmroz@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Alergologii i Pneumonologii
- Principal Investigator Name
- Marta Chełminska
- Principal Investigator Email
- marta.chelminska@gumed.edu.pl
- Contact Person Name
- Marta Chełminska
- Contact Person Email
- marta.chelminska@gumed.edu.pl
- Site Name
- Centrum Medyczne All-Med Badania Kliniczne
- Principal Investigator Name
- Grazyna Pulka
- Principal Investigator Email
- pulkaallmed@gmail.com
- Contact Person Name
- Grazyna Pulka
- Contact Person Email
- pulkaallmed@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 179
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Medical Center New Rehabilitation Center EOOD
- Principal Investigator Name
- Dimo Dimov
- Principal Investigator Email
- dmdimov65@yahoo.com
- Contact Person Name
- Dimo Dimov
- Contact Person Email
- dmdimov65@yahoo.com
- Site Name
- Medical Center Pulmovision Ltd.
- Principal Investigator Name
- Miroslav Mihaylov
- Principal Investigator Email
- mihaylov@pulmovision.com
- Contact Person Name
- Miroslav Mihaylov
- Contact Person Email
- mihaylov@pulmovision.com
- Site Name
- Rahila Angelova Mbal AD
- Department Name
- First internal department - internal diseases II level internal diseases II level
- Principal Investigator Name
- Boyko Boyanov
- Principal Investigator Email
- pernik@rdservices.org
- Contact Person Name
- Boyko Boyanov
- Contact Person Email
- pernik@rdservices.org
- Site Name
- Medical Center Zdrave-1 OOD
- Principal Investigator Name
- Rumen Tiholov
- Principal Investigator Email
- dr_tiholov@abv.bg
- Contact Person Name
- Rumen Tiholov
- Contact Person Email
- dr_tiholov@abv.bg
- Site Name
- Medical Center Excelsior OOD
- Principal Investigator Name
- Todor Popov
- Principal Investigator Email
- ted.popov@gmail.com
- Contact Person Name
- Todor Popov
- Contact Person Email
- ted.popov@gmail.com
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Principal Investigator Name
- Georgi Hinkov
- Principal Investigator Email
- drhinkov@abv.bg
- Contact Person Name
- Georgi Hinkov
- Contact Person Email
- drhinkov@abv.bg
- Site Name
- Medical Center Hermes Ruse Ltd.
- Principal Investigator Name
- Nikolay Evgeniev
- Principal Investigator Email
- nikolay.evgeniev@gmail.com
- Contact Person Name
- Nikolay Evgeniev
- Contact Person Email
- nikolay.evgeniev@gmail.com
- Site Name
- Medical Center Hera EOOD
- Principal Investigator Name
- Kiril Palaveev
- Principal Investigator Email
- palaveevk@abv.bg
- Contact Person Name
- Kiril Palaveev
- Contact Person Email
- palaveevk@abv.bg
- Site Name
- Medical Center Pulmovision (duplicate listing possible)
- Site Name
- Other listed Bulgarian site
Italy
- Earliest CTIS Part Ii Submission Date
- 22-07-2025
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 183
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- SC Pneumologia
- Principal Investigator Name
- Angelo Guido Corsico
- Principal Investigator Email
- corsico@unipv.it
- Contact Person Name
- Angelo Guido Corsico
- Contact Person Email
- corsico@unipv.it
Germany
- Earliest CTIS Part Ii Submission Date
- 04-06-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 243
- Number Of Sites
- 6
- Number Of Participants
- 32
Sites
- Site Name
- KPPK GmbH
- Department Name
- KPPK Studienzentrum
- Principal Investigator Name
- Olaf Schmidt
- Principal Investigator Email
- schmidt@kppk-gmbh.de
- Contact Person Name
- Olaf Schmidt
- Contact Person Email
- schmidt@kppk-gmbh.de
- Site Name
- POIS Sachsen GmbH
- Department Name
- POIS Sachsen
- Principal Investigator Name
- Falk Brunner
- Principal Investigator Email
- f.brunner@pois-sachsen.de
- Contact Person Name
- Falk Brunner
- Contact Person Email
- f.brunner@pois-sachsen.de
- Site Name
- Research Center for Medical Studies (RCMS)
- Department Name
- RCMS/Lungenpraxis Hohenzollerndamm
- Principal Investigator Name
- Anneliese Linnhoff
- Principal Investigator Email
- Dr.linnhoff@lungenpraxis-hohenzollerndamm.de
- Contact Person Name
- Anneliese Linnhoff
- Contact Person Email
- Dr.linnhoff@lungenpraxis-hohenzollerndamm.de
- Site Name
- IKF Pneumologie GmbH & Co. KG (Frankfurt Am Main)
- Department Name
- IKF Pneumologie GmbH & Co. KG
- Principal Investigator Name
- Oliver Kornmann
- Principal Investigator Email
- Kornmann@ikf-pneumologie.de
- Contact Person Name
- Oliver Kornmann
- Contact Person Email
- Kornmann@ikf-pneumologie.de
- Site Name
- ME Clinical Respiratory Research Hamburg GmbH
- Department Name
- ME Clinical Respiratory Research Hamburg GmbH
- Principal Investigator Name
- Martin Ehlers
- Principal Investigator Email
- martin.ehlers@clinical-respiratory-research.com
- Contact Person Name
- Martin Ehlers
- Contact Person Email
- martin.ehlers@clinical-respiratory-research.com
- Site Name
- IKF Pneumologie GmbH & Co. KG (Mainz)
- Department Name
- IKF Pneumologie GmbH & Co. KG
- Principal Investigator Name
- Stephanie Korn
- Principal Investigator Email
- korn@ikf-pneumologie.de
- Contact Person Name
- Stephanie Korn
- Contact Person Email
- korn@ikf-pneumologie.de
Sponsor
Primary sponsor
- Full Name
- Upstream Bio Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Operational roles (sponsor duties coded: 1,10,11,12,2,3,5,6,7,8) as listed in CTIS record
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- IMP packaging and distribution
- Name
- PPD Global Central Labs
- Responsibilities
- Central Laboratory
Third parties
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"eCOA, respiratory services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Analysis, storage and transfer of biological samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Alcami Carolinas Corp.","duties_or_roles":"Analysis, storage and transfer of biological samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Operational roles (sponsor duties coded: 1,10,11,12,2,3,5,6,7,8) as listed in CTIS record","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IMP packaging and distribution","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Verekitug (UPB-101)
- Active Substance
- HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST CRLF2
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- MIA number: DE BW 01 MIA 2023 0054
- Frequency
- Every 12 weeks (Q12W)
- Investigational Product Name
- Veritikug (UPB-101) matching solution for subcutaneous injection with no active treatment
- Modality
- Other
- Authorisation Status
- MIA number: DE BW 01 MIA 2023 0054
- Frequency
- Administered as matching placebo at dosing visits (Q12W when applicable)
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