Clinical trial • Phase II • Immunology

IANALUMAB for Diffuse cutaneous systemic sclerosis (dcSSc)

Phase II trial of IANALUMAB for Diffuse cutaneous systemic sclerosis (dcSSc).

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Diffuse cutaneous systemic sclerosis (dcSSc)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
28-06-2024
First CTIS Authorization Date
21-10-2024

Trial design

Randomised, placebo to vay736 150 mg/1 ml solution for injection in pre-filled syringe-controlled Phase II trial across 48 sites in Poland, Belgium, Germany and others.

Randomised
Yes
Comparator
Placebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe
Target Sample Size
138
Trial Duration For Participant
364

Eligibility

Recruits 138 adults.

Inclusion criteria

  • {"criterion_text":"- Male and female participants ≥ 18 and ≤ 70 years (at the time of the screening visit)."}
  • {"criterion_text":"- Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy et al 1988)"}
  • {"criterion_text":"- Disease duration of ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)"}
  • {"criterion_text":"- mRSS units of ≥ 15 and ≤ 45 at the time of the screening visit"}
  • {"criterion_text":"- Active disease that meets at least one of the following criteria at screening: •\tDisease duration of ≤ 18 months defined as time from the first non−Raynaud phenomenon manifestation •\tIncrease in mRSS of ≥ 3 units compared with the most recent assessment performed within the previous 6 months •\tInvoed within the previous 6 months •\tInvolvement of one new body area and an increase in mRSS of ≥ 2 units compared with the most recent assessment performlvement of two new body areas within the previous 6 months •\tElevated acute phase reactants (ESR) ≥ 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) ≥ 6 mg/L) •\tPresence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity •\tModified EUSTAR disease activity index (mDAI) ≥ 2.5"}
  • {"criterion_text":"- Participant must be positive for at least one of the following autoantibodies: •\tanti-topoisomerase I (ATA) (also known as anti-SCL-70) •\tanti-RNA polymerase III (anti-RNAP3) •\tanti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA /anti-RNAP3) will be limited to 30% of the overall randomized study population."}

Exclusion criteria

  • {"criterion_text":"- Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary."}
  • {"criterion_text":"- Participants treated with cyclophosphamide within 12 weeks prior to Baseline."}
  • {"criterion_text":"- Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)"}
  • {"criterion_text":"- Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria"}
  • {"criterion_text":"- Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit"}
  • {"criterion_text":"- Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded"}
  • {"criterion_text":"- Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation."}
  • {"criterion_text":"- Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit"}
  • {"criterion_text":"- Previous improvement (decrease) in mRSS > 10 units"}
  • {"criterion_text":"- Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit"}
  • {"criterion_text":"- WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 3/5 rCRISS25 response at Week 52","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in FVC% predicted at Week 52.","definition_or_measurement_approach":"Change from baseline in percent-predicted forced vital capacity (FVC%) at Week 52."}
  • {"endpoint_text":"- To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52.","definition_or_measurement_approach":"Change from baseline in modified Rodnan Skin Score (mRSS) at Week 52."}
  • {"endpoint_text":"- Change from baseline in HAQ-DI at Week 52.","definition_or_measurement_approach":"Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52."}
  • {"endpoint_text":"- Ianalumab concentrations in serum during treatment and Follow-up Period","definition_or_measurement_approach":"Measurement of ianalumab serum concentrations during treatment and follow-up (pharmacokinetics)."}
  • {"endpoint_text":"- Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time","definition_or_measurement_approach":"Incidence and titre of anti-drug antibodies (immunogenicity) measured in serum over time."}
  • {"endpoint_text":"- Safety evaluation includes adverse events, laboratory parameters, and vital signs","definition_or_measurement_approach":"Safety assessed via adverse events, laboratory tests and vital signs monitoring."}

Recruitment

Planned Sample Size
138
Recruitment Window Months
71
Consent Approach
Informed consent is obtained from adult participants (≥18 years). Adult informed consent forms (Main ICF) and molecular pre-screening ICFs are provided; ICFs are available in multiple languages (examples in submitted documents include English, German, French, Dutch, Polish, Portuguese, Greek, Italian, Spanish, Hungarian). Specific assent/consent handling for vulnerable populations is not described in the available documents.

Geography

Total Number Of Sites
48
Total Number Of Participants
62

Poland

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
577
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
1801 : Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Contact Person Name
Iwona Dankiewicz-Fares
Contact Person Email
iwonadankiewiczfares@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
1802 : Centrum Medyczne Warszawa
Contact Person Name
Katarzyna Romanowska-Prochnicka

Belgium

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
208
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
UZ Leuven
Department Name
2900 : Rheumatology
Contact Person Name
Ellen De Langhe
Contact Person Email
Delanghe.ellen@uzleuven.be

Germany

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
567
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
2401 : Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie (CCM)
Contact Person Name
Fredrik Albach
Contact Person Email
fredrik.albach@charite.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
2404 : Klinik für Innere Medizin III, Rheumatologie/Osteologie
Contact Person Name
Alexander Pfeil
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
2405 : Medizinische Klinik und Poliklinik II
Contact Person Name
Marc Schmalzing
Contact Person Email
Schmalzing_M@ukw.de

Portugal

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
567
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
3401: Serviço de Reumatologia
Contact Person Name
Maria João Salvador Henriques
Contact Person Email
uid@ulscoimbra.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
3400: Serviço de Reumatologia
Contact Person Name
Catarina Resende
Contact Person Email
cic@chln.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
3402: Serviço de Reumatologia
Contact Person Name
Tiago Meirinhos

Spain

Earliest CTIS Part Ii Submission Date
24-09-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
571
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
1502: Reumatology
Contact Person Name
Sara Manrique Arija
Contact Person Email
sarama_82@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
1504: Reumatology
Contact Person Name
Jose Maria Álvaro-Gracia
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
1501: Reumatology
Contact Person Name
Ivan Castellví Barranco
Contact Person Email
ICastellvi@santpau.cat
Site Name
Hospital Universitario De Salamanca
Department Name
1503: Reumatology
Contact Person Name
Susana Gómez de Castro
Contact Person Email
sgomezc@saludcastillayleon.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
1505: Reumatology
Contact Person Name
Juan José Alegre Sancho
Contact Person Email
alegre_juasan@gva.es

Hungary

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
568
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Semmelweis University
Department Name
2200: Semmelweis Egyetem - Reumatológiai és Immunológiai Klinika
Contact Person Name
Anna Anna
Contact Person Email
bazsoanna@yahoo.com
Site Name
University Of Pecs
Department Name
2201: Reumatology and Immunology Clinic
Contact Person Name
Gabor Kumanovics
Contact Person Email
kumanovics.gabor@pte.hu
Site Name
University Of Debrecen
Department Name
2202: Department of Rheumatology
Contact Person Name
Gabriella Szucs
Contact Person Email
szucs.gabriella@med.unideb.hu

France

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
567
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
2504:Department of Internal Medicine
Contact Person Name
Gregory PUGNET
Contact Person Email
pugnet.g@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
2500:Department of Internal Medicine
Contact Person Name
David LAUNAY
Contact Person Email
David.LAUNAY@CHRU-LILLE.FR
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
2502:Rhumatology Department
Contact Person Name
Emmanuel CHATELUS
Site Name
Assistance Publique Hopitaux De Paris
Department Name
2506:Department of Internal Medicine
Contact Person Name
Luc MOUTHON
Contact Person Email
luc.mouthon@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
2501:Department of Internal Medicine and clinical immunology
Contact Person Name
Alain LESCOAT
Contact Person Email
Alain.LESCOAT@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
2503:Department of Internal Medicine and Clinical Immunology
Contact Person Name
Bernard BONNOTTE
Contact Person Email
bernard.bonnotte@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
2508:Department of Internal Medicine
Contact Person Name
Sebastien RIVIERE
Contact Person Email
sebastien.riviere@aphp.fr
Site Name
Centre Hospitalier Le Mans
Department Name
2505:Rhumatology and Immunology
Contact Person Name
Paul LEGENDRE
Contact Person Email
plegendre@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
2507:Rhumatology Department
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Dijon (additional site entry)
Department Name
2503:Department of Internal Medicine and Clinical Immunology

Italy

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
569
Number Of Sites
17
Number Of Participants
17

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
2005:U.O.C. Reumatologia
Contact Person Name
Giuliana Guggino
Contact Person Email
giuliana.guggino@unipa.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
2006:Divisione Reumatologia e Immunologia Clinica
Contact Person Name
Maria De Santis
Contact Person Email
maria.de_santis@hunimed.eu
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
2003:SC Reumatologia
Contact Person Name
Veronica Codullo
Contact Person Email
v.codullo@smatteo.pv.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
2007:U.O.C. Reumatologia
Contact Person Name
Maria Antonietta D’Agostino
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
2000:U.O.C.Reumatologia Clinica
Contact Person Name
Nicoletta Del Papa
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
2004:S.O.D. Clinica Medica
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@staff.univpm.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
2001:U.O.C. di Reumatologia
Contact Person Name
Luca Idolazzi
Contact Person Email
luca.idolazzi@univr.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
2008:U.O.C. Reumatologia
Contact Person Name
Dilia Giuggioli
Contact Person Email
dilia.giuggioli@unimore.it

Austria

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
556
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Medical University Of Graz
Department Name
3300 : Internal Medicines
Contact Person Name
Jens Thiel
Contact Person Email
Jens.thiel@medunigraz.at

Greece

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
627
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Laiko General Hospital Of Athens
Department Name
2300:Department of Physiology and Pathophysiology
Contact Person Name
Clio Mavragani
Contact Person Email
kmauragan@med.uoa.gr
Site Name
University General Hospital Of Alexandroupoli
Department Name
2301 : 1st Clinic of Internal Medicine
Contact Person Name
Charalampos Papagoras
Contact Person Email
charispapagoras@yahoo.com
Site Name
Athens Naval Hospital
Department Name
2302:Rheumatology Department
Contact Person Name
Gkikas Katsifis
Contact Person Email
katsifisg@yahoo.gr

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: 1
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 1
Name
PRA Hellas CRO A.E.
Responsibilities
sponsorDuties codes: 1
Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties codes: 12
Name
PPD Global Limited
Responsibilities
sponsorDuties codes: 13
Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 13/3/1 (multiple entries)

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Clinigma ApS","duties_or_roles":"sponsorDuties codes: 13","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"sponsorDuties codes: 13","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 13","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Transportation and Travel Reimbursement Services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: 13","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (second entry)","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"sponsorDuties codes: 13","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patients guides and tools, HCP engagement materials","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VAY736
Active Substance
IANALUMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
Placebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe
Modality
Other

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