Chronic Inflammatory Demyelinating PolyradiculoneuropathyPhase 2/3emlightNCT07638566
A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
A Phase 2/3 study testing Empasiprubart IV in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), run by argenx.
Trial summary
The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), CIDP
- What is being tested?
- Empasiprubart IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Aug 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is aged 12 to <18 years.
- Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.
Who cannot join
- Possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- Sensory CIDP (including sensory-predominant CIDP).
- Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP, or that puts the participant at undue risk.
- Prior use of other long-acting immunomodulatory treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.
The study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.
The overall study duration for each participant is up to 43 months.
More information can be found here: clinicaltrials.argenx.com/emlight
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Being tested
- Empasiprubart IV
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empasiprubart IVBiological
Intravenous infusions of empasiprubart
| Study group | Role | What they receive |
|---|---|---|
| Empasiprubart IV | Experimental | Participants will receive empasiprubart IV Receives: Biological: Empasiprubart IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empasiprubart serum concentrations as input for a population PK-driven analysis to determine the effect of age and body size on CL and Vd
CL = Clearance; Vd = apparent volume of distribution.
Measured: Up to 8 weeks
Free and total C2 levels as input for PK/PD modeling analysis
C2 = complement component 2.
Measured: Up to 8 weeks
Secondary outcomes (4)
Incidence of AEs, SAEs and AESIs
AE = Adverse event ; SAE = Serious adverse event ; AESI = Adverse event of special interest.
Measured: Up to 180 weeks
Empasiprubart serum concentrations over time
Measured: Up to 180 weeks
Percentage reductions from baseline of free and total C2 levels over time
C2 = complement component 2.
Measured: Up to 180 weeks
Incidence of ADA and NAb against empasiprubart in serum
ADA = antidrug antibody(ies); NAb = neutralizing antibody(ies).
Measured: Up to 180 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638566
- Sponsor's protocol ID
- ARGX-117-6-CIDP-2001
- Other IDs
- 2025-524153-14-00, 2025
- Acronym
- emlight
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- ClinicalTrials.gov ID
- NCT07638566
- Acronym / sponsor ID
- emlight / ARGX-117-6-CIDP-2001
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.
The study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.
The overall study duration for each participant is up to 43 months.
More information can be found here: clinicaltrials.argenx.com/emlight
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empasiprubart IV | Experimental | Biological: Empasiprubart IVParticipants will receive empasiprubart IV |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Is aged 12 to <18 years.
- Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.
Key exclusion criteria (4 listed)
- Possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- Sensory CIDP (including sensory-predominant CIDP).
- Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP, or that puts the participant at undue risk.
- Prior use of other long-acting immunomodulatory treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empasiprubart IVIntravenous infusions of empasiprubart | Biological | Empasiprubart IV |
Primary outcome
Empasiprubart serum concentrations as input for a population PK-driven analysis to determine the effect of age and body size on CL and Vd
Time frame: Up to 8 weeks
CL = Clearance; Vd = apparent volume of distribution.
Free and total C2 levels as input for PK/PD modeling analysis
Time frame: Up to 8 weeks
C2 = complement component 2.
4 secondary outcomes
Incidence of AEs, SAEs and AESIs
Time frame: Up to 180 weeks
Empasiprubart serum concentrations over time
Time frame: Up to 180 weeks
Percentage reductions from baseline of free and total C2 levels over time
Time frame: Up to 180 weeks
Incidence of ADA and NAb against empasiprubart in serum
Time frame: Up to 180 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Empasiprubart IV in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), run by argenx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empasiprubart serum concentrations as input for a population PK-driven analysis to determine the effect of age and body size on CL and Vd (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.