Study on Batoclimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a treatment called Batoclimab, which is a solution for injection. Batoclimab is also known by its code name IMVT-1401. The trial will compare the effects of Batoclimab to a placebo in adult participants who have active CIDP.

The purpose of the study is to evaluate how effective Batoclimab is in maintaining a clinical response in people with CIDP who are already receiving treatments like immune globulin or plasma exchange. Participants will be randomly assigned to receive either Batoclimab or a placebo. The study will be conducted over a period of time, and participants will receive regular injections. The trial aims to see if Batoclimab can help prevent relapses, which are periods when symptoms worsen.

Throughout the study, participants will be monitored to assess their response to the treatment. This will include checking for any changes in their condition and measuring their strength and ability to perform daily activities. The study will help determine if Batoclimab is a safe and effective treatment option for people with CIDP.

1 joining the study

Upon joining the study, participation is confirmed for individuals aged 18 or older who have been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) or its variants.

Eligibility is based on specific clinical criteria and diagnostic tests that support the diagnosis of CIDP.

2 treatment administration

Participants receive either the medication batoclimab or a placebo. The placebo is identical in appearance but contains no active substance.

The medication is administered as a subcutaneous injection, which means it is injected under the skin.

3 monitoring and assessment

Throughout the study, participants are monitored to evaluate the effectiveness of the treatment in maintaining clinical response.

Assessments include measuring changes in the adjusted inflammatory neuropathy cause and treatment (Adj INCAT) score, grip strength, and other disability scales.

4 evaluation of outcomes

The primary goal is to determine the proportion of participants who remain free from relapse at Week 36.

Secondary outcomes include the time to first relapse and changes in various clinical scores from the baseline to Week 36.

5 completion of the study

The study is expected to conclude by January 31, 2027.

Participants’ health and response to the treatment are evaluated at the end of the study period.

Who Can Join the Study?

  • You must be 18 years or older at the time of the Screening Visit.
  • You should have been diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is a condition affecting the nerves, or one of its variants like multifocal, focal, or motor CIDP.
  • For typical CIDP, you should have:
    • Muscle weakness that is getting worse or comes and goes, affecting both sides of the body, and involves both the upper and lower limbs.
    • Symptoms that have developed over at least 8 weeks.
    • Reduced or absent reflexes in all limbs.
  • For CIDP variants, you should have:
    • Multifocal CIDP: Sensory loss and muscle weakness in different areas, usually more in the upper limbs.
    • Focal CIDP: Sensory loss and muscle weakness in only one limb.
    • Motor CIDP: Only motor symptoms without sensory issues.
  • You need to have test results that support the diagnosis of CIDP, which may include:
    • Tests showing nerve issues that suggest demyelination, which means damage to the protective covering of nerves.
    • Improvement after treatment with immunoglobulin, plasma exchange, or corticosteroids.
    • Imaging tests like ultrasound or MRI showing nerve enlargement.
    • Spinal fluid tests showing high protein levels but normal white blood cell levels.
    • Nerve biopsy showing signs of CIDP like swelling or damage to the nerve covering.
  • For Cohort C, you must have a diagnosis of CIDP with strong evidence from nerve tests.
  • For Cohort D, you must meet the clinical criteria for typical CIDP or one of its variants.
  • There are additional criteria that are detailed in the study protocol.

Who Cannot Join the Study?

  • Patients who are not currently receiving treatments like immune globulin (IVIg or SCIg) or plasma exchange (PLEX) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a condition that affects the nerves, causing weakness and numbness.
  • Patients who are not able to maintain a clinical response, which means their condition is not stable or improving with current treatments, are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might have additional health or social challenges, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Galen Clinic Lublin Poland
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Universitaet Leipzig Leipzig Germany
Katholieke Universiteit te Leuven Leuven Belgium
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Katholisches Klinikum Bochum gGmbH Bochum Germany
Univerzitna Nemocnica Martin Martin Slovakia
Fakultna Nemocnica Trnava Trnava Slovakia
University General Hospital Of Heraklion Heraklion Greece
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Liptovsky Mikulas Slovakia
401 General Military Hospital Of Athens Athens Greece
General University Hospital Of Larissa Larissa Greece
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
University General Hospital Of Ioannina Ioannina Greece
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Turku University Hospital Turku Finland
Universita’ Di Pisa Pisa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
General University Hospital Of Patras Patras Greece
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Neurocentrum Bydgoszcz Sp. z o.o. Bydgoszcz Poland
Rigshospitalet Copenhagen Denmark
Eginitio Hospital Athens Greece
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Universitair Ziekenhuis Gent Gent Belgium
Charite Research Organisation GmbH Berlin Germany
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov Presov Slovakia
Ftiajuknug Sfesdu Ozsbu &jxznhf Cgqytr Cyiazss Nsni Bmeqtup Brescia Italy
Fcabqbafct Izoynixb Njuuobxygjo Mwvrkjj Ilvke [eyxazpoe di Rhjgihav e Cbly a Cgtjbcips Sdzcznzvookw Pavia Italy
Msliqyjd Meugysu Ayljmzi &mjshen Mtmzonooqtck Hjbbgbql few Ayogwf Twuvhzzob &ewflfx Ptnzjc Pleven Bulgaria
Icxhzmgwwz Ncwpkbdat db Nlpapzixnt Åmo Bfyz Nutxgzseedeprs Bvrvabaudm Bucharest Romania
Cvultwurq Gbapcja Hkczalzf Barcelona Spain
Mgctsjhgr Imxkcinfvd Cuqzppno Seywaxkh Soq z ohge Warsaw Poland
Crqvzja Mwxauish Hhqb Chjrch Lublin Poland
Asxdadh Ozplvcowgng Uskzvkfbjpbdg Slmfba Siena Italy
Haeieyyi Dr Le Swbim Chfw I Sjaa Pue Barcelona Spain
Akzonsb Onszmygmwsm Piym Gisalacz Xsatg Bergamo Italy
Kjpnxbtxi Soqdkvy Svezyfbgxgrpjra ib Japu Pbepi Ix Cracow Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.11.2022
Bulgaria Bulgaria
Not recruiting
02.11.2022
Denmark Denmark
Not recruiting
02.11.2022
Finland Finland
Not recruiting
02.11.2022
Germany Germany
Not recruiting
02.11.2022
Greece Greece
Not recruiting
02.11.2022
Italy Italy
Not recruiting
02.11.2022
Norway Norway
Not recruiting
02.11.2022
Poland Poland
Not recruiting
02.11.2022
Portugal Portugal
Not recruiting
02.11.2022
Romania Romania
Not recruiting
02.11.2022
Slovakia Slovakia
Not recruiting
02.11.2022
Spain Spain
Not recruiting
02.11.2022
Sweden Sweden
Not recruiting
02.11.2022

Trial locations

Investigated drugs:

Batoclimab is a medication being studied for its potential to help people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. The trial is looking at how well Batoclimab can maintain the clinical response in patients who are already receiving other treatments for CIDP.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease typically progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of reflexes. Over time, these symptoms can lead to difficulties with walking and coordination. CIDP is considered a chronic condition, meaning it can persist for a long time and may require ongoing management. The progression of the disease can vary greatly among individuals, with some experiencing periods of improvement and others having a steady decline.

Trial ID:
2024-512646-42-00
Protocol code:
IMVT-1401-2401
Trial Phase:
Therapeutic exploratory (Phase II)

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