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New shot shows promise for long-term platelet control in rare bleeding disorder

NCT ID NCT04812925

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called efgartigimod given as a shot under the skin for adults with primary immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding risks. The goal is to see if the drug is safe and helps maintain safe platelet levels over a year. Participants must have completed a prior efgartigimod study. The treatment is meant to control the disease long-term, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

173 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits). 2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case. 3a. Agree to use contraceptives consistent with local regulations and the following: • Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply: 4\. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 5\. Participant has completed a 52-week treatment period. Exclusion criteria: 1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines) 2. Use of any other investigational drug or participation in any other investigational trial 3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients 4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura primary thrombocytopenia Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary immune thrombocytopenia

Contacts and locations

Locations

  • Investigator Site 0010062

    Fort Wayne, Indiana, 46804, United States

  • Investigator Site 0010095

    Oklahoma City, Oklahoma, 73142, United States

  • Investigator Site 0010116

    Bentonville, Arkansas, 72758, United States

  • Investigator Site 0070026

    Moscow, Russia

  • Investigator Site 0070037

    Novosibirsk, Russia

  • Investigator Site 0070038

    Nizhny Novgorod, Russia

  • Investigator Site 0300009

    Thessaloniki, Greece

  • Investigator Site 0390032

    Milan, Italy

  • Investigator Site 0390044

    Naples, Italy

  • Investigator Site 0400005

    Bucharest, Romania

  • Investigator Site 0400007

    Craiova, Romania

  • Investigator Site 0480026

    Nowy Sącz, Poland

  • Investigator Site 0480037

    Skorzewo, Poland

  • Investigator Site 0540001

    Buenos Aires, Argentina

  • Investigator Site 0610003

    West Perth, Australia

  • Investigator Site 0610012

    Garran, Australia

  • Investigator Site 0660001

    Bangkok Noi, Thailand

  • Investigator Site 0660002

    Bangkok, Thailand

  • Investigator Site 0660003

    Bangkok, Thailand

  • Investigator Site 0810017

    Iruma, Japan

  • Investigator Site 0810038

    Tama, Japan

  • Investigator Site 0810051

    Kitakyushu, Japan

  • Investigator Site 0810053

    Kanagawa, Japan

  • Investigator Site 0860001

    Tianjin, China

  • Investigator Site 0860002

    Wuxi, China

  • Investigator Site 0860008

    Bengbu, China

  • Investigator Site 0860010

    Wuhan, China

  • Investigator Site 0860011

    Zhengzhou, China

  • Investigator Site 0860015

    Shenzhen, China

  • Investigator Site 0900003

    Ankara, Turkey (Türkiye)

  • Investigator Site 0900007

    Adapazarı, Turkey (Türkiye)

  • Investigator Site 0900008

    Ankara, Turkey (Türkiye)

  • Investigator Site 0900014

    Kocaeli, Turkey (Türkiye)

  • Investigator Site 0900015

    Ankara, Turkey (Türkiye)

  • Investigator Site 3510007

    Lisbon, Portugal

  • Investigator Site 3590017

    Plovdiv, Bulgaria

  • Investigator Site 9950007

    Tbilisi, Georgia

  • Investigator site 0010045

    Washington D.C., District of Columbia, 20007, United States

  • Investigator site 0070040

    Kirov, Russia

  • Investigator site 0470003

    Sarpsborg, 1714, Norway

  • Investigator site 0560003

    Reñaca, Chile

  • Investigator site 0560004

    Temuco, Chile

  • Investigator site 0660004

    Chiang Mai, 50200, Thailand

  • Investigator site 0810016

    Shibukawa, 377-0280, Japan

  • Investigator site 0900017

    Tekirdağ, 59100, Turkey (Türkiye)

  • Investigator site 2160002

    Tunis, Tunisia

  • Investigator site 2610001

    Sousse, Tunisia

  • Investigator site 270001

    Pretoria, South Africa

  • Investigator site 270002

    Randburg, South Africa

  • Investigator site 270003

    Johannesburg, South Africa

  • Investigator site 270004

    Observatory, South Africa

  • Investigator site 300008

    Athens, Greece

  • Investigator site 3510001

    Vila Nova de Gaia, Portugal

  • Investigator site 3510004

    Porto, Portugal

  • Investigator site 3530003

    Dublin, Ireland

  • Investigator site 390041

    Naples, Italy

  • Investigator site 390043

    Ferrara, Italy

  • Investigator site 400012

    Bucharest, Romania

  • Investigator site 440005

    Coventry, United Kingdom

  • Investigator site 520002

    Aguascalientes, Mexico

  • Investigator site 540004

    Buenos Aires, Argentina

  • Investigator site 560002

    Santiago, Chile

  • Investigator site 610005

    Westmead, Australia

  • Investigator site 640005

    Christchurch, New Zealand

  • Investigator site 660005

    Bangkok, Thailand

  • Investigator site 810023

    Shimotsuke, Japan

  • Investigator site 820004

    Seoul, South Korea

  • Investigator site 860013

    Beijing, China

  • Investigator site 860055

    Huizhou, China

  • Investigator site 860058

    Zhenjiang, China

  • Investigator site 900004

    Izmir, Turkey (Türkiye)

  • Investigator site 900010

    Mersin, Turkey (Türkiye)

  • Investigator site 900019

    Trabzon, Turkey (Türkiye)

  • Investigator site 9620001

    Irbid, Jordan

  • Investigator site 9950009

    Tbilisi, Georgia

  • Investigator site 9950011

    Tbilisi, Georgia

  • Investigator site JP0810015

    Hirakata, 5731191, Japan

  • Investigator site KO0820007

    Seoul, South Korea

  • Investigator site PL0480013

    Katowice, 40-519, Poland

  • Investigator site TH0660009

    Khon Kaen, Thailand

  • Investigator site UK0440014

    Penzance, TR18 2PF, United Kingdom

  • Investigator site UK044041

    London, United Kingdom

  • Investigator site US0010042

    Iowa City, Iowa, 52242, United States

More trials for these conditions

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