ClinicalTrials.gg
Not yet recruitingNCT07789483LTSAFE-ALXNUpdated Aug 28, 2026

An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of ALXN2220 in Adults With Transthyretin Amyloid Cardiomyopathy

A Phase 3 interventional study of ALXN2220 in Transthyretin Amyloid Cardiomyopathy (ATTR-CM), sponsored by Alexion Pharmaceuticals, Inc.. Not yet recruiting at 195 sites in 27 countries. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,180
Allocation
Not applicable
Sex
All
01

Study summary

The purpose of Study ALXN2220-ATTRCM-302 is to evaluate the long-term safety, tolerability and efficacy of ALXN2220 in adult participants with ATTR-CM treated with ALXN2220 in addition to SoC who have completed Study ALXN2220-ATTRCM-301.

02

Conditions studied

  • Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Keywords

  • ALXN2220
  • Cliramitug
  • NI006
  • Transthyretin Amyloid Cardiomyopathy
  • ATTR-CM
  • Open-Label Extension Study
03

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.

Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.

First submitted after Alexion Pharmaceuticals, Inc. became part of AstraZeneca.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type of Participant: Participants who have completed the Blinded Treatment Period (including the PC visit) of Study 301.
  • Sex and /Barrier Requirements: Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement).
  • : Participant, or legally authorized representative where relevant and allowed by law, is willing and able to comply with all study requirements and to provide signed informed consent.

Exclusion criteria

  • Participants who permanently discontinued study intervention in Study 301
  • Participants who withdrew full consent during Study 301.
  • Medical Conditions: Suspected or known intolerance/allergy to proteins or any components of ALXN2220. Has had a heart transplant or permanent CMAD implantation. Has any new or worsening of existing medical or psychological condition or risk factor that in the opinion of the Investigator or Sponsor might jeopardize participant's safety or compliance with the protocol, or pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
  • Prior/Concurrent/Future Clinical Study Experience: Current or future participation in another clinical study or intake of investigational drug within 30 calendar days or 5 half-lives of the study intervention, whichever is longer, before signing the ICF, except for study intervention used in Study 301.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,180 participants (estimated)

Study arms

  • Experimental
    ALXN2220

    Eligible participants will receive ALXN2220 administered IV q4w for a minimum of 12 months and up to 24 months or until participant has access to commercially available ALXN2220 for ATTR-CM, whichever occurs first.

    Drug: ALXN2220

Interventions

  • To be administered as an IV infusion

    Also known as: Cliramitug, NI006

06

What researchers measure

Primary outcomes

  1. Percentage of participants with TEAEs

    To evaluate the long-term safety and tolerability of ALXN2220 in participants with ATTR-CM

    Time frame: Up to 24 months

Secondary outcomes

  1. Total occurrence of ACM and CV clinical events

    To evaluate the long-term efficacy of ALXN2220 on ACM and CV clinical events

    Time frame: Up to 24 months

  2. Total occurrence of CV clinical events

    To evaluate the long-term efficacy of ALXN2220 on CV clinical events

    Time frame: Up to 24 months

  3. Time to ACM

    To evaluate the long-term efficacy of ALXN2220 on ACM

    Time frame: Up to 24 months

  4. Time to first CV clinical event or ACM

    To evaluate the long-term efficacy of ALXN2220 on first CV clinical event or ACM

    Time frame: Up to 24 months

  5. Time to CVM

    To evaluate the long-term efficacy of ALXN2220 on CVM

    Time frame: Up to 24 months

  6. Change from baseline in KCCQ-OS by visit

    To assess the long-term efficacy of ALXN2220 on symptoms, functionality, and health-related QoL.

    Time frame: Up to 24 months

  7. Change from baseline in 6MWT by visit

    To assess the long-term efficacy of ALXN2220 on functional capacity

    Time frame: Up to 24 months

  8. ADA incidence, response categories, and titer

    To assess long-term immunogenicity to ALXN2220

    Time frame: Up to 24 months

  9. NAb incidence and response categories

    To assess long-term immunogenicity to ALXN2220

    Time frame: Up to 24 months

07

Study locations

195 sites
  • Research Site
    Irvine, California 92614, United States
  • Research Site
    La Jolla, California 92037, United States
  • Research Site
    Palo Alto, California 94304, United States
  • Research Site
    San Francisco, California 94143, United States
  • Research Site
    Aurora, Colorado 80045, United States
  • Research Site
    Washington D.C., District of Columbia 20010, United States
  • Research Site
    Jacksonville, Florida 32224, United States
  • Research Site
    Weston, Florida 33331, United States
  • Research Site
    Atlanta, Georgia 30309, United States
  • Research Site
    Atlanta, Georgia 30322, United States
  • Research Site
    Indianapolis, Indiana 46202, United States
  • Research Site
    Boston, Massachusetts 02115, United States
  • Research Site
    Boston, Massachusetts 02118, United States
  • Research Site
    Kansas City, Missouri 64111, United States
  • Research Site
    St Louis, Missouri 63110, United States
  • Research Site
    New York, New York 10016, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    Stony Brook, New York 11794, United States
  • Research Site
    Chapel Hill, North Carolina 27599, United States
  • Research Site
    Durham, North Carolina 27705, United States
  • Research Site
    Cleveland, Ohio 44195, United States
  • Research Site
    Columbus, Ohio 43210, United States
  • Research Site
    Portland, Oregon 97239, United States
  • Research Site
    Danville, Pennsylvania 17822, United States
  • Research Site
    Philadelphia, Pennsylvania 19104, United States
  • Research Site
    Charleston, South Carolina 29425, United States
  • Research Site
    Greenville, South Carolina 29605, United States
  • Research Site
    Memphis, Tennessee 38120, United States
  • Research Site
    Fort Worth, Texas 76104, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    Salt Lake City, Utah 84132, United States
  • Research Site
    Falls Church, Virginia 22042, United States
  • Research Site
    Richmond, Virginia 23298, United States
  • Research Site
    Seattle, Washington 98195, United States
  • Research Site
    Madison, Wisconsin 53705, United States
  • Research Site
    Buenos Aires, Buenos Aires 1425, Argentina
  • Research Site
    CABA, Buenos Aires C1025ABI, Argentina
  • Research Site
    Ciudad de Buenos Aires, Buenos Aires F.D. C1181ACH, Argentina
  • Research Site
    Córdoba, Córdoba Province X5016KEH, Argentina
  • Research Site
    Ciudad de Buenos Aires, C1428, Argentina
  • Research Site
    Darlinghurst, New South Wales 2010, Australia
  • Research Site
    Westmead, New South Wales 2145, Australia
  • Research Site
    Brisbane, Queensland 4102, Australia
  • Research Site
    Bedford Park, South Australia 5042, Australia
  • Research Site
    Box Hill, Victoria 3128, Australia
  • Research Site
    Melbourne, Victoria 3004, Australia
  • Research Site
    Joondalup, Western Australia 6027, Australia
  • Research Site
    Graz, 8036, Austria
  • Research Site
    Innsbruck, 6020, Austria
  • Research Site
    Vienna, 1090, Austria
  • Research Site
    Vienna, 1160, Austria
  • Research Site
    Wels, 4600, Austria
  • Research Site
    Bruges, West-Vlaanderen 8000, Belgium
  • Research Site
    Genk, 3600, Belgium
  • Research Site
    Fortaleza, Ceará 60430-375, Brazil
  • Research Site
    Rio de Janeiro, Rio de Janeiro 20551-030, Brazil
  • Research Site
    Rio de Janeiro, Rio de Janeiro 22270-005, Brazil
  • Research Site
    Porto Alegre, Rio Grande do Sul 90560-030, Brazil
  • Research Site
    Campinas, São Paulo 13083, Brazil
  • Research Site
    Ribeirão Preto, São Paulo 14026-020, Brazil
  • Research Site
    Ribeirão Preto, São Paulo 14051-140, Brazil
  • Research Site
    São Paulo, São Paulo 04012-909, Brazil
  • Research Site
    São Paulo, São Paulo 05403-000, Brazil
  • Research Site
    São Paulo, São Paulo 05652-900, Brazil
  • Research Site
    Calgary, Alberta T2N 1N4, Canada
  • Research Site
    Winnipeg, Manitoba R2H 2A6, Canada
  • Research Site
    London, Ontario N6A 5A5, Canada
  • Research Site
    Chicoutimi, Quebec G7H 5H6, Canada
  • Research Site
    Montr Al, Quebec H1T 1C8, Canada
  • Research Site
    Montr Al, Quebec H2X 1R9, Canada
  • Research Site
    Rimouski, Quebec G5L 5T1, Canada
  • Research Site
    Beijing, Beijing Municipality 100037, China
  • Research Site
    Beijing, Beijing Municipality 100191, China
  • Research Site
    Chongqing, Chongqing Municipality 400042, China
  • Research Site
    Guangzhou, Guangdong 510080, China
  • Research Site
    Guiyang, Guizhou 550044, China
  • Research Site
    Harbin, Heilongjiang 150080, China
  • Research Site
    Wuhan, Hubei 430030, China
  • Research Site
    Changsha, Hunan 430033, China
  • Research Site
    Nanjing, Jiangsu 210029, China
  • Research Site
    Xi'an, Shaanxi 710061, China
  • Research Site
    Jinan, Shangdong 250021, China
  • Research Site
    Shanghai, Shanghai Municipality 201114, China
  • Research Site
    Hangzhou, Zhejiang 310003, China
  • Research Site
    Hangzhou, Zhejiang 310009, China
  • Research Site
    Beijing, 100730, China
  • Research Site
    Tianjin, 300457, China
  • Research Site
    Praha, Central Bohemia 140 00, Czechia
  • Research Site
    Prague, 128 08, Czechia
  • Research Site
    Aarhus, 8200, Denmark
  • Research Site
    Odense C, 5000, Denmark
  • Research Site
    Bron, 69677, France
  • Research Site
    Chambray-lès-Tours, 37170, France
  • Research Site
    Créteil, 94010, France
  • Research Site
    Marseille, 13005, France
  • Research Site
    Montpellier, 34295, France
  • Research Site
    Paris, 75018, France
  • Research Site
    Paris, 75651, France
  • Research Site
    Pessac, 33604, France
  • Research Site
    Poitiers, 86021, France

Showing the first 100 of 195 sites across 27 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2027; primary completion for Jul 2030, 31 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 28, 2026
StartEst.
Nov 23, 2027
Primary completionEst.
Jul 11, 2030
CompletionEst.
Jul 11, 2030
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789483
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Nov 23, 2027 (estimated)
Primary completion
Jul 11, 2030 (estimated)
Completion
Jul 11, 2030 (estimated)
Last update
Aug 28, 2026

Study contacts

Alexion Pharmaceuticals, Inc., Sponsor
Contact
clinicaltrials@alexion.com
1-855-752-2356

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cliramitug

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