Who is sponsoring NCT04281472?

NCT04281472 is sponsored by argenx.

What drugs are being tested in NCT04281472?

Interventions in NCT04281472: efgartigimod PH20 SC in stage B, placebo in stage B.

What condition does NCT04281472 study?

NCT04281472 studies Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Is NCT04281472 still recruiting?

NCT04281472 is currently completed. Last updated 20 August 2024.

Are results published for NCT04281472?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-20 · How we verify

NCT04281472: ADHERE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Completed Phase 2 Results posted Last updated 20 August 2024

What this trial tests

Phase 2 trial testing efgartigimod PH20 SC in stage B in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in 322 participants. Completed in 11 May 2023.

Timeline

15 April 2020

Primary endpoint
11 May 2023

11 May 2023

Quick facts

Lead sponsor	argenx
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	322
Start date	15 April 2020
Primary completion	11 May 2023
Estimated completion	11 May 2023
Sites	216 locations across Italy, Japan, Taiwan, Poland, Denmark, Netherlands, Russia, Belgium

Drugs / interventions tested

efgartigimod PH20 SC in stage B — full drug profile →
placebo in stage B

Conditions studied

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) — all drugs for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) →

Sponsor

argenx — full company profile →

Who can join

18 and older, any sex, with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stage A: Percentage of Participants With Confirmed Evidence of Clinical Improvement(ECI) Primary · Up to 12 weeks during the open-label stage A

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	66.5	61.0 – 71.6

Stage B: Time to First Adjusted INCAT Deterioration Compared to Stage B Baseline Primary · Up to 48 weeks during the randomized placebo-controlled stage B

Group	Value	95% CI
Stage B: Efgartigimod PH20 SC	NA	NA – NA
Stage B: Placebo PH20 SC	140.0	75.0 – NA

Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) Secondary · Up to 12 weeks during the open-label stage A

25th percentile

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	22	22.0 – 23.0

50th percentile (median)

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	43.0	31.0 – 51.0

75th percentile

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	71.0	70.0 – 78.0

Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Adjusted INCAT Score Secondary · Up to 12 weeks during the open-label stage A

Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) scores range from 0-10 with a score of 10 indicating the greatest degree of disability.

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-0.9	± 1.71

Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Medical Research Council (MRC) Sum Score Secondary · Up to 12 weeks during the open-label stage A

The Medical Research Council (MRC) Sum scores range from 0 to 60 with a lower score indicating greater muscle weakness.

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	3.8	± 0.41

Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in I-RODS Disability Scores Secondary · Up to 12 weeks during the open-label stage A

The Inflammatory Rasch-built Overall Disability Scale (I-RODS) score ranges from 0-100, with lower scores indicating the greatest degree of disability.

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	7.7	± 15.48

Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in TUG Score Secondary · Up to 12 weeks during the open-label stage A

The Timed Up and Go (TUG) score is calculated as the number of seconds needed to complete a series of actions. The longer time needed to complete this test (expressed in seconds) indicates lower mobility.

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-4.3	± 0.83

Stage A: Change From Stage A Baseline to Last Assessment in Stage A, in Mean Grip Strength Secondary · Up to 12 weeks during the open-label stage A

This is measured with a handheld device called a vigometer

dominant hand

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	12.3	± 18.68

nondominant hand

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	11.2	± 21.12

Stage A: Exposure Adjusted Occurrence of Treatment-emergent Adverse Events and Serious Adverse Events Secondary · Up to 12 weeks during the open-label stage A

Treatment-emergent (serious) AEs expressed in number of events/100 PYFU (participant years of follow-up)

Exposure Adjusted Occurrence of Treatment-emergent Adverse Events

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	1343.1

Exposure Adjusted Occurrence of Treatment-emergent Serious Adverse Events

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	51.2

Stage A: Pre-dosing Efgartigimod Serum Concentrations Over Time Secondary · Up to 13 weeks during the open-label stage A (12 weeks + optional 1 additional week to confirm evidence of clinical improvement (ECI))

Week 1

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	14.9	± 6.92

Week 2

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	19.6	± 8.55

Week 3

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	19.7	± 9.62

Week 4

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	18.9	± 9.96

Week 5

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	18.4	± 8.38

Week 6

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	19.2	± 9.62

Week 7

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	17.3	± 8.89

Week 8

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	18.8	± 8.93

Stage A: Percent Changes From Stage A Baseline of Serum IgG Levels Over Time Secondary · Up to 13 weeks during the open-label stage A (12 weeks + optional 1 additional week to confirm evidence of clinical improvement (ECI))

Percent change from Baseline to Week 1

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-36.1	± 0.58

Percent change from Baseline to Week 2

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-54.6	± 0.80

Percent change from Baseline to Week 3

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-63.5	± 0.71

Percent change from Baseline to Week 4

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-66.2	± 0.89

Percent change from Baseline to Week 5

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-67.9	± 0.74

Percent change from Baseline to Week 6

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-67.7	± 1.42

Percent change from Baseline to Week 7

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-66.4	± 1.96

Percent change from Baseline to Week 8

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	-64.5	± 4.28

Stage A: Number of Participants With Binding Antidrug Antibodies (ADA) Towards Efgartigimod or Antibodies (Ab) Against rHuPH20 and Neutralizing Antibodies (NAb) Against Efgartigimod and/or rHuPH20 Secondary · Up to 12 weeks during the open-label stage A

ADA towards Efgartigimod incidence

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	20

Ab towards rHuPH20 incidence

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	45

NAb against Efgartigimod incidence

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	1

NAb against rHuPH20 incidence

Group	Value	95% CI
Stage A: Efgartigimod PH20 SC	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 60 weeks (12 weeks during Stage A and 48 weeks during Stage B). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stage A: Efgartigimod PH20 SC

Serious: 21/322 (7%)

Deaths: 2/322

Stage B: Efgartigimod PH20 SC

Serious: 6/111 (5%)

Deaths: 0/111

Stage B: Placebo PH20 SC

Serious: 6/110 (5%)

Deaths: 1/110

Serious adverse events (21 terms)

Reaction	System	Stage A: Efgartigimod PH20…	Stage B: Efgartigimod PH20…	Stage B: Placebo PH20 SC
CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY	Nervous system disorders	—	—	—
PNEUMONIA	Infections and infestations	—	—	—
CARDIAC ARREST	Cardiac disorders	—	—	—
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	—	—	—
COVID-19	Infections and infestations	—	—	—
COVID-19 PNEUMONIA	Infections and infestations	—	—	—
SUSPECTED COVID-19	Infections and infestations	—	—	—
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
QUADRIPARESIS	Nervous system disorders	—	—	—
CALCULUS URINARY	Renal and urinary disorders	—	—	—
DEAFNESS UNILATERAL	Ear and labyrinth disorders	—	—	—
CHOLELITHIASIS	Hepatobiliary disorders	—	—	—
APPENDICITIS	Infections and infestations	—	—	—
CONCUSSION	Injury, poisoning and procedural complications	—	—	—
FOOT FRACTURE	Injury, poisoning and procedural complications	—	—	—
DEHYDRATION	Metabolism and nutrition disorders	—	—	—
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
URETHRAL STENOSIS	Renal and urinary disorders	—	—	—
URINARY BLADDER POLYP	Renal and urinary disorders	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Stage A: Efgartigimod PH20…	Stage B: Efgartigimod PH20…	Stage B: Placebo PH20 SC
INJECTION SITE ERYTHEMA	General disorders	—	—	—
COVID-19	Infections and infestations	—	—	—
HEADACHE	Nervous system disorders	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—
INJECTION SITE BRUISING	General disorders	—	—	—

Most-reported serious reactions: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY, PNEUMONIA, CARDIAC ARREST, CLOSTRIDIUM DIFFICILE COLITIS, COVID-19, COVID-19 PNEUMONIA, SUSPECTED COVID-19, SQUAMOUS CELL CARCINOMA OF SKIN.

Data from ClinicalTrials.gov NCT04281472 adverse events section.

Sponsor's own description

This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The therapeutic age of the neonatal Fc receptor.
Pyzik M, Kozicky LK, Gandhi AK, Blumberg RS. · · 2023 · cited 166× · PMID 36726033 · DOI 10.1038/s41577-022-00821-1
Efgartigimod: First Approval.
Heo YA. · · 2022 · cited 108× · PMID 35179720 · DOI 10.1007/s40265-022-01678-3
Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial.
Allen JA, Lin J, Basta I, Dysgaard T, et al · · 2024 · cited 55× · PMID 39304241 · DOI 10.1016/s1474-4422(24)00309-0
Therapeutic Monoclonal Antibody Therapies in Chronic Autoimmune Demyelinating Neuropathies.
Briani C, Visentin A. · · 2022 · cited 39× · PMID 35349079 · DOI 10.1007/s13311-022-01222-x
Neonatal Fc Receptor-Targeted Therapies in Neurology.
Nelke C, Spatola M, Schroeter CB, Wiendl H, et al · · 2022 · cited 32× · PMID 34997443 · DOI 10.1007/s13311-021-01175-7
Fc-Receptor Targeted Therapies for the Treatment of <i>Myasthenia gravis</i>.
Keller CW, Pawlitzki M, Wiendl H, Lünemann JD. · · 2021 · cited 14× · PMID 34071155 · DOI 10.3390/ijms22115755
Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.
Gjølberg TT, Mester S, Calamera G, Telstad JS, et al · · 2025 · cited 10× · PMID 40156757 · DOI 10.1007/s40259-025-00708-2
Repurposing MS immunotherapies for CIDP and other autoimmune neuropathies: unfulfilled promise or efficient strategy?
Kohle F, Dalakas MC, Lehmann HC. · · 2023 · cited 8× · PMID 36620728 · DOI 10.1177/17562864221137129

Verify or expand the search:

Other recruiting trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Currently open trials in the same condition.

NCT07526493 — Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Media · Phase 1 · recruiting
NCT07337785 — CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT06040567 — Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study · recruiting
NCT04280718 — A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic · Phase 2 · active not recruiting

Other argenx trials

Trials by the same sponsor.

NCT07377396 — A Study to Assess the Safety of ARGX-124 in Healthy Volunteers · Phase 1 · recruiting
NCT07287982 — A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration · Phase 2 · recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With · Phase 2 · recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip · recruiting
NCT07091630 — A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04281472 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by argenx
Last refreshed: 20 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04281472.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing