Clinical trial • Phase II • Immunology|Rare Disease
DNTH103 for Multifocal motor neuropathy
Phase II trial of DNTH103 for Multifocal motor neuropathy.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Multifocal motor neuropathy
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 06-09-2024
- First CTIS Authorization Date
- 17-12-2024
Trial design
Randomised, open-label, matching placebo to dnth103 (matching placebo to dnth103). dose and schedule not specified in the record.-controlled Phase II trial in Spain, France, Denmark and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Matching placebo to DNTH103 (Matching placebo to DNTH103). Dose and schedule not specified in the record.
- Target Sample Size
- 25
- Trial Duration For Participant
- 980
Eligibility
Recruits 25 Must have given written informed consent before any study-related activities are carried out. Caregiver informed consent forms are provided (e.g., documents titled 'L1_Caregiver ICF_Redacted' and country-specific caregiver ICFs). No vulnerable population selected in the trial metadata (isVulnerablePopulationSelected=false)..
- Pregnancy Exclusion
- Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
- Vulnerable Population
- Must have given written informed consent before any study-related activities are carried out. Caregiver informed consent forms are provided (e.g., documents titled 'L1_Caregiver ICF_Redacted' and country-specific caregiver ICFs). No vulnerable population selected in the trial metadata (isVulnerablePopulationSelected=false).
Inclusion criteria
- {"criterion_text":"- Must have given written informed consent before any study-related activities are carried out\n- Adult males and females, 18 to 75 years of age (inclusive)\n- Weight range between 40 to 120 kg\n- Confirmed diagnosis of definite or probable MMN\n- Evidence of: a. Responsiveness to Ig treatment; and b. Receiving a stable Ig regimen\n- Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability\n- Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n- Male participants must be surgically sterile for at least 90 days prior to Screening or agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception"}
Exclusion criteria
- {"criterion_text":"- History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments\n- Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes\n- Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements\n- Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy)\n- Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization\n- Currently or previously on complement inhibitors including in a clinical trial setting\n- Prior history (at any time) of N. meningitidis infection\n- Diagnosis of an autoimmune disorder other than MMN\n- Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening\n- History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone\n- Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Time to retreatment with immunoglobulin (Ig) since the final Ig treatment before randomization\n- Time to clinical deterioration (CD)\n- Mean value, mean change, and percentage change from baseline in grip strength\n- Area under curve (AUC) of the change from baseline in grip strength\n- AUC of the change from baseline in Medical Research Council (MRC)-10 sum score\n- Mean value and mean change from baseline in MRC-10 sum score\n- Mean value and mean change from baseline in MRC-14 sum score\n- Mean value and mean change from baseline in Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale (MMN-RODS) score\n- Mean value and mean change from baseline in average time to complete the 9-Hole Peg Test (9-HPT)\n- Mean change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability score\n- Mean change from baseline in Euro-Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) scale\n- Mean change from baseline in EQ-5D-5L visual analog scale (VAS)\n- Count and proportion of participants with Patient Global Impression of Change (PGIC) score of improved or better\n- Mean change from baseline in Fatigue Severity Scale (FSS) score\n- Mean change from baseline in Health-Related Productivity Questionnaire (HRPQ) outcomes\n- Effectiveness, side effects, convenience, and overall satisfaction scores as assessed by Treatment Satisfaction Questionnaire for Medications (TSQM)-14\n- Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)\n- Serum concentrations of DNTH103\n- Incidence and titer of antidrug antibody (ADA) levels against DNTH103","definition_or_measurement_approach":""}
Recruitment
- Registry Or Advocacy Recruitment
- True, GBS CIDP Foundation
- Digital Remote Recruitment
- True — website postings (country-specific), patient-facing electronic materials and use of ePRO (patient diary) services (third party P1vital Products Limited listed with duty 'ePRO (patient diary)')
- Planned Sample Size
- 25
- Recruitment Window Months
- 39
- Consent Approach
- Written informed consent is required: 'Must have given written informed consent before any study-related activities are carried out.' Participant information and informed consent forms are provided as Part 1 and Part 2 ICFs (documents: 'L1_Participant Part 1 ICF_Redacted', 'L1_Participant Part 2 ICF_Redacted' and country-specific versions). Caregiver ICFs and biobanking ICFs are also provided. Patient-facing documents and ICFs are available in multiple languages (English, Danish, French, Italian, Polish, Spanish, Dutch) as per document list.
Methods
- Website postings / online postings (document titles include 'K2_GBS CIDP Foundation Website Posting', 'K2_Website_fr_Redacted', 'K2_Foundation Website Posting_Redacted') — patient-facing website materials targeted to patients and advocacy audiences (country-specific versions present).
- Patient brochures and flyers (document titles include 'K2_Patient Brochure', 'K2_Patient Flyer' and country-specific variants) — printed / downloadable patient-facing materials.
- Recruitment procedures/arrangements documents (document titles include 'K1_Recruitment arrangements_Public', 'K1_Recruitment procedure') — procedural documentation for recruitment implemented at sites/countries.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 11
Spain
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 420
- Number Of Sites
- 4
- Number Of Participants
- 1
Sites
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Neurology
- Contact Person Name
- Carmen Diaz Marin
- Contact Person Email
- Carmina.diaz.marin@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Contact Person Name
- Raul Juntas Morales
- Contact Person Email
- raul.juntas@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Contact Person Name
- Raul Sevilla Mantecón
- Contact Person Email
- sevilla_ter@gva.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Contact Person Name
- Luis Querol Gutiérrez
- Contact Person Email
- lquerol@santpau.cat
France
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 445
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- referenece center for neuromusculars disorders and ALS
- Contact Person Name
- Shahram Attarian
- Contact Person Email
- shahram.attarian@ap-hm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurology
- Contact Person Name
- Alain Créange
- Contact Person Email
- alain.creange@aphp.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 414
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Rigshospitalet
- Department Name
- Neuromuscular Clinic and Research Unit
- Contact Person Name
- Tina Dysgaard
- Contact Person Email
- tina.dysgaard@regionh.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Neuromuscular Clinic
- Contact Person Name
- Thomas Harbo
- Contact Person Email
- tfb@dadlnet.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 420
- Number Of Sites
- 4
- Number Of Participants
- 1
Sites
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Contact Person Name
- Lukasz Rzepinski
- Contact Person Email
- luk.rzepinski@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Neurologii
- Contact Person Name
- Agnieszka Slowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Neurologia Slaska Centrum Medyczne
- Contact Person Name
- Marek Smilowski
- Contact Person Email
- marek.smilowski@neurologiaslaska.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddzial Neurologiczny
- Contact Person Name
- Agnieszka Kulaga
- Contact Person Email
- a.kulaga@szpitaljp2.krakow.pl
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 225
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Neurology and Neurosurgery
- Contact Person Name
- Willem-Lodewijk Van der Pol
- Contact Person Email
- w.l.vanderPol@umcutrecht.nl
- Site Name
- Amsterdam UMC Research B.V.
- Department Name
- Neurology
- Contact Person Name
- Filip Eftimov
- Contact Person Email
- f.eftimov@amsterdamumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 416
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- Systems Medicine
- Contact Person Name
- Girolama Alessandra Marfia
- Contact Person Email
- marfia@uniroma2.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Malattie Neuromuscolari e Neuroimmunologia
- Contact Person Name
- Claudia Cutellè
- Contact Person Email
- cludia.cutelle@humanitas.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOC Neurologia
- Contact Person Name
- Matteo Garibaldi
- Contact Person Email
- metteo.garibaldi@uniroma1.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- UOC Neurologia
- Contact Person Name
- Loris Poli
- Contact Person Email
- loris.poli@asst-spedalicivili.it
Sponsor
Primary sponsor
- Full Name
- Dianthus Therapeutics Inc.
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Worldwide Clinical Trials d.o.o.
- Responsibilities
- sponsorDuties codes: 1, 11, 12, 13, 14, 2, 5, 6, 8
- Name
- PPD Global Central Labs
- Responsibilities
- sponsorDuties code: 4 (central lab services)
- Name
- QPS LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- sponsorDuties code: 4
- Name
- Kcas LLC
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"United States","full_name":"Merative US LP","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties code: 15; value: blood samples storage","organisation_type":"Pharmaceutical company"}
- {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"sponsorDuties codes: 1, 11, 12, 13, 14, 2, 5, 6, 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"China","full_name":"Wuxi Biologics Co. Ltd.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"P1vital Products Limited","duties_or_roles":"sponsorDuties code: 15; value: ePRO (patient diary)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- DNTH103
- Active Substance
- DNTH103
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Route
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Investigational Product Name
- Matching placebo to DNTH103
- Modality
- Other
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