Clinical trial • Phase IV • Respiratory

Pentavalent nanobody consisting of two nanobody building blocks targeting TSLP, two nanobody building blocks targeting IL-13 and one nanobody building block targeting human albumin for Asthma

Phase IV trial of Pentavalent nanobody consisting of two nanobody building blocks targeting TSLP, two nanobody building blocks targeting IL-13 and one nan…

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Asthma
Trial Stage
Phase IV
Drug Modality
Other antibody

Key dates

Initial CTIS Submission Date
24-10-2025
First CTIS Authorization Date
02-03-2026

Trial design

open-label, none/not specified-controlled Phase IV trial in Belgium, Denmark, France and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
780

Eligibility

Recruits 780 Vulnerable population selected. Participants must be capable of giving signed informed consent. Individuals accommodated in an institution because of regulatory or legal order (prisoners or legally institutionalized participants) are explicitly excluded..

Pregnancy Exclusion
Contraception for male and female participants For female participants: o incapable of becoming pregnant o not pregnant or breast feeding o no eggs donation or cryopreserving eggs For male participants: o No sperm donation or cryopreserving sperm
Vulnerable Population
Vulnerable population selected. Participants must be capable of giving signed informed consent. Individuals accommodated in an institution because of regulatory or legal order (prisoners or legally institutionalized participants) are explicitly excluded.

Inclusion criteria

  • {"criterion_text":"- Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol\n- Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated: o For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone o For Study ACT18301: LABA with or without LTRA.\n- Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures.\n- Contraception for male and female participants For female participants: o incapable of becoming pregnant o not pregnant or breast feeding o no eggs donation or cryopreserving eggs For male participants: o No sperm donation or cryopreserving sperm\n- Capable of giving signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- Participants are excluded from the study if any of the following criteria apply: - Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator’s medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures.\n- Participant who was diagnosed with a new pulmonary disease which may impair lung function.\n- Current smoker or active vaping of any products and/or marijuana smoking.\n- Prescription drug or substance abuse, including alcohol, considered significant by the Investigator.\n- History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study\n- Participants who are receiving prohibited concomitant medications\n- Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant.\n- Concurrent participation in any other clinical study, including non-interventional studies.\n- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n- Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)","definition_or_measurement_approach":"Count of participants experiencing any TEAE, AESI or SAE (treatment-emergent adverse events as reported during study visits)."}

Secondary endpoints

  • {"endpoint_text":"- Annualized rate of asthma exacerbation events\n- Annualized rate of asthma exacerbation events\n- Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)\n- Change from parent study baseline in pre bronchodilator (BD) FEV1\n- Change from parent study baseline in Asthma Control Questionnaire-5 (ACQ-5) score\n- Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score\n- Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score\n- Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score\n- Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] + 12) domain and total scores\n- Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores\n- Serum lunsekimig concentrations\n- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig","definition_or_measurement_approach":"Endpoints include annualized exacerbation rates (events per year), changes from parent study baseline in pre-bronchodilator FEV1 (measured by spirometry), changes in ACQ-5 and AQLQ[S]+12 scores (validated questionnaires), proportion achieving ≥0.5-point reduction versus parent baseline, serum drug concentration measurements (PK assays), and incidence/titer of anti-drug antibodies (ADA) measured by immunoassay."}

Recruitment

Planned Sample Size
780
Recruitment Window Months
37
Consent Approach
Participants must be capable of giving signed informed consent. Subject information and informed consent forms (L1) and related materials are provided in multiple languages (documents available in English, French, Spanish, Hungarian, Dutch, Polish, German, Italian, Swedish, Danish based on submitted ICF and patient-facing documents). Partner/pregnancy information sheets are available where applicable.

Geography

Total Number Of Sites
59
Total Number Of Participants
90

Belgium

Earliest CTIS Part Ii Submission Date
30-01-2026
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
31
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Emmaues
Department Name
AZ Sint Maarten( #1)
Contact Person Name
Muriel Lins
Contact Person Email
muriel.lins@emmaus.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Universitair Ziekenhuis Gent
Contact Person Name
Guy Brusselle
Contact Person Email
guy.brusselle@uzgent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
CHU de Liège( #1)
Contact Person Name
Renaud Louis
Contact Person Email
r.louis@chu.ulg.ac.be

Denmark

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
13
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Lillebaelt Hospital
Department Name
Lung Clinic
Contact Person Name
Ole Hilberg
Contact Person Email
ole.hilberg@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Lungemedicinsk og Endokrinologisk Afdeling
Contact Person Name
Charlotte Suppli Ulrik
Contact Person Email
csulrik@dadlnet.dk

France

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
81
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
"CENTRE D'INVESTIGATION CLINIQUE 11ème étage - Aile Nord"
Contact Person Name
Camille Taillé
Contact Person Email
camille.taille@bch.aphp.fr
Site Name
Clinique De L'Europe
Department Name
Clinique de l'Europe (#1)
Contact Person Name
Youcef DOUADI
Contact Person Email
y.douadi@ch-stquentin.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Centre d'Investigation Clinique Plurithématique, unité pneumologie,
Contact Person Name
Pierre-Olivier Girodet
Site Name
Hospices Civils De Lyon
Department Name
Service de Pneumologie
Contact Person Name
Gilles Devouassoux
Contact Person Email
gilles.devouassoux@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Asthme et Allergologie
Contact Person Name
Naji Khayath
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service des Maladies Respiratoires
Contact Person Name
Arnaud BOURDIN
Contact Person Email
arnaud01009157@gmail.com
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Département de pneumologie- Pôle voies respiratoires
Contact Person Name
Laurent GUILLEMINAULT

Germany

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
28
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Studienzentrum Dr. Keller
Contact Person Name
Claus Keller
Contact Person Email
ck@praxis-ckeller.de
Site Name
POIS Sachsen GmbH
Department Name
POIS Sachsen
Contact Person Name
Juliana Brode
Contact Person Email
j.brode@pois-sachsen.de
Site Name
Institut für Allergie- und Asthmaforschung Berlin
Contact Person Name
Matthias Krüll
Contact Person Email
kruell@pneumologie-berlin.de
Site Name
KPPK GmbH
Contact Person Name
Olaf Schmidt
Contact Person Email
schmidt@kppk-gmbh.de
Site Name
IKF Pneumologie GmbH & Co. KG
Department Name
IKF Institut für Klinische Forschung Mainz
Contact Person Name
Stephanie Korn
Contact Person Email
korn@ikf-pneumologie.de

Hungary

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
85
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Puespoekladanyi Egeszseguegyi Szolgaltato Intezmeny
Department Name
Püspökladányi Egészségügyi Szolgáltató Nonprofit Kft.( #1)
Contact Person Name
Nelli Kosztyu
Contact Person Email
nellypharmanex@gmail.com
Site Name
Infer-Med Kft.
Department Name
Infer -Med Kft.
Contact Person Name
Marta Papp
Contact Person Email
drpappm@gmail.com
Site Name
Erzsebet Gondozohaz Kft.
Department Name
Erzsébet Gondozóház Kft.( #2)
Contact Person Name
Janos Mucsi
Contact Person Email
mucsitrial@gmail.com
Site Name
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Ildiko Horvath
Contact Person Email
horvath.ildiko@med.unideb.hu
Site Name
Omnimodus Elixir Kft.
Department Name
Omnimodus Elixír Szolgáltató Kft.
Contact Person Name
Erika Ivett Unger
Contact Person Email
ungerstudy@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
28
Number Of Sites
12
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Contact Person Name
Nicola Scichilone
Contact Person Email
nicola.scichilone@unipa.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Person Name
Cristiano Caruso
Site Name
University Hospital Of Ferrara
Department Name
Ospedale Universitario di Ferrara
Contact Person Name
Alberto Papi
Contact Person Email
ppa@unife.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Contact Person Name
Fabiano Di Marco
Contact Person Email
fdimarco@asst-pg23.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
Azienda Ospedaliero-Universitaria Di Cagliari
Contact Person Name
Stefano Del Giacco
Contact Person Email
delgiac@gmail.com
Site Name
Istituti Clinici Scientifici Maugeri S.p.A.
Department Name
Istituti Clinici Scientifici Maugeri S.p.A.
Contact Person Name
Dina Visca
Contact Person Email
dina.visca@icsmaugeri.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Azienda USL IRCCS Di Reggio Emilia
Contact Person Name
Anna Simonazzi
Contact Person Email
anna.simonazzi@ausl.re.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
IRCCS Ospedale Policlinico San Martino
Contact Person Name
Fulvio Braido
Contact Person Email
fulvio.braido@unige.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Azienda Ospedaliero Universitaria di Modena
Contact Person Name
Bianca Beghé
Contact Person Email
bianca.beghe@unimore.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Istituto Clinico Humanitas
Contact Person Name
Giovanni Paoletti
Contact Person Email
giovanni.paoletti@hunimed.eu
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico(#1)
Contact Person Name
Francesco Bruno Arturo Blasi
Contact Person Email
francesco.blasi@unimi.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Azienda Ospedaliero Universitaria Delle Marche
Contact Person Name
Beatrice Maria Bilò
Contact Person Email
m.b.bilo@staff.univpm.it

Spain

Earliest CTIS Part Ii Submission Date
04-02-2026
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
31
Number Of Sites
16
Number Of Participants
16

Sites

Site Name
Hospital La Milagrosa S.A.
Department Name
Consultas Externas
Contact Person Name
Walther Ivan Giron Matute
Contact Person Email
walter_giron2@hotmail.com
Site Name
Clinica Gaias Santiago
Department Name
Pneumology
Contact Person Name
Pedro Penela Penela
Contact Person Email
pedropenelaensayos@gmail.com
Site Name
Pectus Respiratory Health S.L.
Department Name
Pneumology
Contact Person Name
Juan Roldan Sanchez
Site Name
University Hospital Son Espases
Department Name
Hospital Universitari Son Espases(#2)
Contact Person Name
Francisco de Borja Garcia-Cosio Piqueras
Contact Person Email
borja.cosio@ssib.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Pneumology
Contact Person Name
Jose Luis Velasco Garrido
Contact Person Email
jlvelascogarrido@hotmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hospital Universitario Marques De Valdecilla
Contact Person Name
Juan Luis Garcia Rivero
Contact Person Email
jgarcia@separ.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Hospital Regional Universitario de Malaga
Contact Person Name
Carmen Milagros Rondon Segovia
Contact Person Email
carmenrs61@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Allergology
Contact Person Name
Ismael Garcia-Moguel
Contact Person Email
ismaelgmoguel@gmail.com
Site Name
Futuremeds Spain S.L.
Department Name
Pneumology
Contact Person Name
Jesus Fernandez Frances
Contact Person Email
jesus.fernandez@futuremeds.com
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Neumología
Contact Person Name
David Romero Ribate
Contact Person Email
davizrom@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pneumology
Contact Person Name
Christian Eduardo Romero Velasco
Contact Person Email
christian.romero@vhir.org
Site Name
Pectus Respiratoy Health S.L. (BCN)
Department Name
Pectus Respiratoy Health S.L. (BCN)
Contact Person Name
Juan Roldan Sanchez
Site Name
Hospital Germans Trias I Pujol
Department Name
Hospital Universitari Germans Trias i Pujol(#1)
Contact Person Name
Carlos Martinez Rivera
Site Name
FutureMeds Spain Madrid
Department Name
FutureMeds Spain Madrid
Contact Person Name
Jesus Fernandez Frances
Contact Person Email
jesus.fernandez@futuremeds.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hospital Gregorio Marañon
Contact Person Name
Luis Puente Maestu
Contact Person Email
lpuente@separ.es
Site Name
Hospital Vithas Xanit Internacional
Department Name
Hospital Vithas Xanit Internacional
Contact Person Name
Gustavo Adolfo De Luiz Martinez
Contact Person Email
neumologix@yahoo.com

Sweden

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
112
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Gothia Forum, Clinical Trial Center
Contact Person Name
Sara Fristorp Cesarini
Contact Person Email
sara.cesarini@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Lungforskning Solna
Contact Person Name
Apostolos Bossios
Contact Person Email
apostolos.bossios@ki.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Lung-och allergiforskning
Contact Person Name
Jens Christian Richter
Contact Person Email
jens.richter@skane.se

Poland

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
42
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
EMC Instytut Medyczny S.A.
Department Name
"EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium"
Contact Person Name
Grazyna Skarupa-Szablowska
Contact Person Email
grasza66@interia.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
SPZOZ, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi, Klinika Immunologii i Alergii
Contact Person Name
Aleksandra Wardzyńska
Site Name
Wojewodzki Szpital Specjalistyczny Im. Sw. Rafala W Czerwonej Gorze
Department Name
Wojewodzki Szpital Specjalistyczny Im. Św. Rafała w Czerwonej Górze
Contact Person Name
Piotr Łacwik
Contact Person Email
lacwik@gmail.com
Site Name
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
Department Name
Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Contact Person Name
Anna Olech-Cudzik
Contact Person Email
annacudzik@cudmed.pl
Site Name
Gyncentrum Sp. z o.o.
Department Name
Gyncentrum Sp. z o.o.
Contact Person Name
Marta Frejowska-Reniecka
Site Name
Alergologia Plus Sp. z o.o.
Department Name
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapi
Contact Person Name
Michal Springer
Contact Person Email
michal.springer.pl@gmail.com

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Suvoda LLC
Responsibilities
sponsorDuties code 3
Name
Pharmaceutical Product Development LLC
Responsibilities
sponsorDuties code 4
Name
eResearchTechnology GmbH
Responsibilities
sponsorDuties code 7
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties code 7

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Ashfield Iberia S.L.","duties_or_roles":"Home Health Care / Nursing (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
lunsekimig (SAR443765)
Active Substance
Pentavalent nanobody consisting of two nanobody building blocks targeting TSLP, two nanobody building blocks targeting IL-13 and one nanobody building block targeting human albumin
Modality
Other antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Combination Treatment
Yes

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