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Chelating Agent

ALXN1840 for Wilson's Disease

Phase 3
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Summary

This trial tests ALXN1840, a new medicine for Wilson Disease, in patients aged 12 and older. It aims to see if it works better than usual treatments by helping remove excess copper from the body. ALXN1840 is a new treatment for Wilson Disease, which traditionally involves chelation therapy to remove excess copper.

Eligible Conditions
  • Wilson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Daily Mean Area Under The Effect-time Curve (AUEC) of Directly Measured Non-ceruloplasmin-bound Copper (dNCC) From 0 to 48 Weeks (dNCC AUEC0-48W)
Secondary study objectives
Absolute Change From Baseline in Calculated Non-Ceruloplasmin Bound Copper (cNCC) or Calculated Non-Ceruloplasmin Bound Copper Corrected (cNCCcorrected) in Plasma at Week 48
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Week 48
Change From Baseline in Model for End-Stage Liver Disease (MELD) Score at Week 48
+8 more

Side effects data

From 2018 Phase 2 trial • 29 Patients • NCT02273596
36%
Alanine aminotransferase increased
32%
Aspartate aminotransferase increased
29%
Urinary tract infection
29%
Gamma-glutamyltransferase increased
21%
Hepatic enzyme increased
21%
Headache
21%
Fatigue
18%
Tremor
14%
Back pain
14%
Constipation
14%
Rash
11%
Insomnia
11%
Sleep disorder
11%
Diarrhoea
11%
Arthralgia
11%
Depression
11%
Cough
11%
Anxiety
11%
Leukopenia
11%
Sinusitis
11%
Blood alkaline phosphatase increased
7%
Muscle spasms
7%
Dupuytren's contracture
7%
Decreased appetite
7%
Dysgeusia
7%
Blood creatine phosphokinase increased
7%
Dry skin
7%
Vomiting
7%
Myalgia
7%
Fall
7%
Erythema
7%
Pain in extremity
7%
Plantar fasciitis
7%
Paraesthesia
7%
Nausea
7%
Liver function test increased
7%
Neck pain
7%
Depressed mood
7%
Influenza
7%
Tonsillitis
7%
Upper respiratory tract infection
4%
Syncope
4%
Mania
4%
Dysphagia
4%
Neutropenia
4%
Psychotic disorder
4%
Neurological decompensation
4%
Abnormal behaviour
4%
Adjustment disorder
4%
Personality disorder
4%
Gait disturbance
4%
Agranulocytosis
4%
Hepato-lenticular degeneration
4%
Affective disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALXN1840

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ALXN1840Experimental Treatment1 Intervention
ALXN1840 was administered orally for 48 weeks at doses ranging from 15 milligrams (mg) every other day (QOD) up to a titrated dose of 60 mg daily. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period.
Group II: Standard of Care (SoC) MedicationActive Control1 Intervention
SoC medication was administered for 48 weeks. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN1840
2020
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
39,056 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,142 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
257 Previous Clinical Trials
40,851 Total Patients Enrolled
~29 spots leftby Sep 2025
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