Comparison of TAK-881 and HyQvia for adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

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What is this study about?

This study focuses on Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a condition affecting the nerves that can cause weakness and reduced sensation in the arms and legs. The study will evaluate a medication called TAK-881, comparing it to another medication called HyQvia. Both medications contain human normal immunoglobulin, which helps fight infections and regulate the immune system.

The purpose of this research is to compare how these medications work in the body when given under the skin (through subcutaneous injection). The study will use various medical devices including an infusion pump and special needle sets to deliver the medication. Participants will receive treatment for approximately 27 weeks.

During the study, participants will receive either TAK-881 or HyQvia through regular injections under the skin. The medication will be given using specialized equipment to ensure proper delivery. Blood samples will be collected to measure the levels of the medication in the body over time.

1 Initial treatment phase

You will receive HyQvia treatment through subcutaneous infusion (under the skin) for a period of at least 12 weeks

The treatment will be given with a dosage between 0.4 to 2.4 grams per kilogram of body weight per month

The infusions will be administered every 2 to 6 weeks, depending on your individual treatment plan

2 Transition to study medication

After the initial phase, you will transition to receiving TAK-881, the study medication

The medication will continue to be given through subcutaneous infusion

The dosing schedule and amount will remain similar to your previous treatment

3 Monitoring period

Your body’s response to the medication will be monitored through regular blood tests

The main focus will be on measuring the levels of antibodies (IgG) in your blood

Your neurological symptoms will be assessed using a standardized scale called INCAT disability score

4 Study completion

The study will continue until sufficient data is collected to compare both medications

Regular assessments will continue throughout the study period

The study is expected to conclude by May 2030

Who Can Join the Study?

Must be able to understand and follow all study procedures, as determined by the study doctor
Must provide written informed consent before starting any study procedures
Must be at least 18 years old
Must have a confirmed diagnosis of CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) by a nerve disease specialist
Must have shown improvement with previous immunoglobulin (IgG) treatment
Must be currently receiving stable treatment with immunoglobulin therapy for at least 12 weeks before screening, with specific dosing requirements:
- Monthly dose between 0.4 to 2.4 grams per kilogram of body weight
- Treatment intervals of 2-6 weeks for IGIV
- Weekly or bi-weekly for cIGSC
- Up to 6 weeks for HYQVIA
Must have an INCAT disability score (a measure of disability) between 0 and 7, meeting specific scoring criteria
For participants who can become pregnant:
- Must have a negative pregnancy test at screening
- Must agree to use effective birth control during the study and for 30 days after the last study treatment

Who Cannot Join the Study?

History of severe allergic reactions or anaphylaxis to immunoglobulin treatments (antibody-based medications)
Active thrombosis (blood clots) or high risk of developing blood clots
Severe kidney problems or renal failure
Immunoglobulin A (IgA) deficiency with antibodies against IgA
Pregnant or breastfeeding women
Participation in another clinical trial within the past 30 days
Active infections or severe underlying health conditions
History of thromboembolic events (blood clots that travel through blood vessels) in the past 12 months
Significant liver disease or abnormal liver function tests
Uncontrolled hypertension (high blood pressure)
History of cancer within the past 5 years (except for successfully treated skin cancer)
Known allergies to any components of the study medication
Inability to comply with study procedures or follow-up visits
Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Philipps-Universitaet Marburg	Marburg	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
General University Hospital Of Patras	Patras	Greece
Rigshospitalet	Copenhagen	Denmark
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universita Degli Studi Di Brescia	Brescia	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Clinirem Sp. z o.o.	Lublin	Poland
Awbobp Uometreifb Husoqooq	Aarhus	Denmark
Hmqertka Dh La Sqcnk Cpen I Scvn Pce	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	12.06.2025
Denmark	Recruiting	12.06.2025
Germany	Recruiting	12.06.2025
Greece	Recruiting	12.06.2025
Italy	Recruiting	12.06.2025
Poland	Recruiting	12.06.2025
Spain	Not yet recruiting	12.06.2025
Sweden	Recruiting	12.06.2025

Trial locations

Investigated drugs:

TAK-881 is an investigational medication being studied for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It is administered through subcutaneous injection (under the skin).

HYQVIA is an established medication used to treat chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It is an immune globulin infusion that is administered subcutaneously. The medication helps to provide antibodies that the body needs to protect against infections in people with weakened immune systems.

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) – A neurological disorder that affects the peripheral nerves throughout the body. It occurs when the immune system attacks and damages the protective covering of nerves called myelin. The condition typically develops gradually over several weeks or months, causing progressive weakness and numbness in both arms and legs. Patients may experience decreased reflexes, tingling sensations, and difficulties with balance and coordination. The symptoms usually affect both sides of the body symmetrically and tend to worsen over time if left untreated. CIDP can affect both motor and sensory nerves, leading to muscle weakness and altered sensations.

Trial ID:

2024-517450-95-00

Protocol code:

TAK-881-3003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparison of TAK-881 and HyQvia for adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?