Study of DNTH103 Treatment for Adults with Chronic Inflammatory Demyelinating Polyneuropathy: Comparing Effectiveness with Placebo

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What is this study about?

This study focuses on Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves outside the brain and spinal cord, causing weakness, numbness, and tingling in the arms and legs. The study will test a new medication called DNTH103, which is given as an injection, compared to placebo. The purpose is to determine how long it takes for symptoms to return (relapse) after treatment with DNTH103.

The study involves two main parts. In the first part, all participants receive DNTH103 to check if they respond to the treatment. In the second part, participants who showed improvement will be randomly assigned to continue receiving either DNTH103 or placebo. The treatment period lasts several months, during which participants will receive regular injections and undergo various assessments to monitor their condition.

Throughout the study, doctors will measure participants’ muscle strength, ability to perform daily activities, and overall quality of life. They will also monitor for any side effects and check how the medication works in the body. The maximum daily dose of DNTH103 will be 1200 mg, and participants may receive treatment for up to 172 days.

1 Initial phase – Part A

You will receive DNTH103 through injection to evaluate your initial response to the treatment.

Your condition will be monitored using several assessment tools, including the adjusted INCAT score (a measure of disability in daily activities) and grip strength tests.

2 Treatment phase – Part B

You will be randomly assigned to receive either DNTH103 or a placebo (a substance with no active medication).

The main focus will be monitoring how long it takes before any symptoms return (relapse).

Regular assessments will measure your muscle strength, daily activity abilities, and overall quality of life.

Your grip strength in both hands will be tested regularly.

You will complete questionnaires about fatigue levels and quality of life.

3 Extended treatment – OLE phase

This phase allows for continued treatment and monitoring.

Regular assessments will continue to track your progress.

Your response to the medication will be monitored through blood tests.

The presence of antibodies against the medication will be checked.

4 Safety monitoring

Throughout the study, you will be monitored for any side effects or unexpected reactions.

Blood samples will be taken to measure the amount of medication in your system.

The study will continue until December 31, 2030.

Who Can Join the Study?

  • Must provide written informed consent before starting any study activities
  • Body weight must be between 40 kilograms and 120 kilograms
  • Must have confirmed diagnosis of CIDP (a type of nerve disorder) or possible CIDP, specifically either typical CIDP or motor/multifocal variants
  • Must have a CIDP Disease Activity Status (CDAS) score of 3 or higher during screening
  • Must be neurologically stable (no recent worsening of symptoms or other neurological events)
  • Must have an adjusted INCAT score (a measure of disability) between 2 and 9
  • Must meet one of these treatment conditions:
    – Currently receiving or previously responded to immunoglobulin treatment
    – Currently receiving or previously responded to corticosteroid treatment
    – Had unsuccessful treatment with standard therapies
    – Never received treatment for CIDP
  • Must have received vaccinations against certain bacteria as required by local guidelines
  • For male participants:
    – Must be surgically sterile for at least 90 days before screening, or
    – Must agree to use contraception and not donate sperm
  • For female participants:
    – Must be unable to bear children, or
    – Must agree to use effective contraception and not donate eggs
    – Must not attempt to become pregnant during the study

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Any other neurological conditions besides Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Current participation in other clinical trials
  • History of severe allergic reactions to medications
  • Pregnant or breastfeeding women
  • Severe kidney or liver disease
  • Uncontrolled diabetes (high blood sugar levels)
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Active infections or ongoing treatment with antibiotics
  • Major surgery within the last 3 months
  • Cancer or history of cancer in the past 5 years
  • Substance abuse or alcohol dependency
  • Mental health conditions that could interfere with the study
  • Unable to provide informed consent
  • Use of immunosuppressive medications other than those specified in the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario Basurto Bilbao Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Gk Neiroklinika Riga Latvia
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Clinical Medical Center Osijek Osijek Croatia
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Universita’ Degli Studi Di Verona Verona Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Centre Hospitalier Universitaire De Nice Nice France
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Association Institut De Myologie Paris France
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Krankenhaus und Poliklinik Ruedersdorf GmbH Rüdersdorf Germany
Fundeni Clinical Institute Bucharest Romania
Aogijhp Salkgplui Leukvd Rhos 1 Rome Italy
Fprlumqqr Kohfflym gmkad Sande Germany
Pdcry Sasrjetihe i Scxfuj Sx zddesb Lublin Poland
Mitm Cxzqxwe Mekejnod Bgysilinf Bydgoszcz Poland
Curnbfp Nsjipiuebv Kvbgzhdke Sthmmu Lodz Poland
Bqoilxkv Cnagfn Srryva Constanta Romania
Ckwfjt Csolxxy Nfsd Milan Italy
Umdoejvxgo Mfrnzxanhcwv Hilwvfiu fpo Axcbjk Tuqabngdm Sbnrj Mhltjj &wkraic Pjevnh Pleven Bulgaria
Cjkdmkz Mqpctayh Hzcw Csvnqf Lublin Poland
Akvseiann Udo Amsterdam The Netherlands
Attdegzcgv Pzvfxknn Hhvjssht Dz Mtdlnczlp Marseille France
Czwwpr Hgoptehjacb Rxmvrhic Uqpdxrizqhycb Dk Tlrqx Tours France
Hruecatg Dz Li Ssdby Cnhx I Sbax Ple Barcelona Spain
Amkqauf Oiuoiehwzfj Pcle Gzbkqtkd Xgrpl Bergamo Italy
Hlcxxaud Uiayyxjesktca Hhxrjauq Tynly y Pihpwn Ivgkumul Cvtqlp dtamoewtfwttaolic (mryn Badalona Spain
Hyfjzrmn Uwxjmoykvkkjpq Sfgbnzqdkh &lfggws Hfyccfp dr Hrpivpfwweb STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.09.2025
Bulgaria Bulgaria
Recruiting
01.09.2025
Croatia Croatia
Not yet recruiting
01.09.2025
Denmark Denmark
Recruiting
01.09.2025
France France
Recruiting
01.09.2025
Germany Germany
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Latvia Latvia
Not yet recruiting
01.09.2025
Poland Poland
Recruiting
01.09.2025
Romania Romania
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025
The Netherlands The Netherlands
Recruiting
01.09.2025

Trial locations

Investigated drugs:

DNTH103 is an investigational medication being studied for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is being tested to see how effective it is at preventing relapses in adults with CIDP. CIDP is a neurological disorder that affects the peripheral nerves, causing weakness, numbness, and tingling in various parts of the body.

Chronic Inflammatory Demyelinating Polyneuropathy – A neurological disorder that affects the peripheral nervous system, where the body’s immune system attacks and damages the protective covering (myelin sheath) of the nerves. The condition develops gradually over several weeks or months, causing progressive weakness and reduced sensation in the arms and legs. It can affect both motor and sensory nerves, leading to muscle weakness, numbness, tingling sensations, and problems with balance and coordination. The symptoms typically affect both sides of the body symmetrically, starting in the legs and potentially spreading to the arms. The condition can fluctuate in severity over time, with periods of worsening and improvement.

Trial ID:
2024-517529-26-00
Protocol code:
DNTH103-CIDP-301
Trial Phase:
Therapeutic confirmatory (Phase III)

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