NCT04225871 (RAISE-XT) is a Phase 3 clinical trial of zilucoplan (RA101495) in Generalized Myasthenia Gravis, sponsored by UCB Biopharma SRL.

Who is sponsoring NCT04225871?

NCT04225871 is sponsored by UCB Biopharma SRL.

What drugs are being tested in NCT04225871?

Interventions in NCT04225871: zilucoplan (RA101495).

What condition does NCT04225871 study?

NCT04225871 studies Generalized Myasthenia Gravis.

Is NCT04225871 still recruiting?

NCT04225871 is currently active, enrolled. Last updated 27 February 2026.

Last reviewed 2026-02-27 · How we verify

NCT04225871: RAISE-XT

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

Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis

Active, enrolled Phase 3 Last updated 27 February 2026

What this trial tests

Phase 3 trial testing zilucoplan (RA101495) in Generalized Myasthenia Gravis in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 December 2019

Primary endpoint
2 June 2026

2 June 2026

Quick facts

Lead sponsor	UCB Biopharma SRL
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	23 December 2019
Primary completion	2 June 2026
Estimated completion	2 June 2026
Sites	70 locations across France, Italy, Japan, United Kingdom, Germany, Poland, Norway, Canada

Drugs / interventions tested

zilucoplan (RA101495) — full drug profile →

Conditions studied

Generalized Myasthenia Gravis — all drugs for Generalized Myasthenia Gravis →

Sponsor

UCB Biopharma SRL — full company profile →

Who can join

18 and older, any sex, with Generalized Myasthenia Gravis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.

Publications & conference data

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

Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study.
Howard JF, Bresch S, Genge A, Hewamadduma C, et al · · 2023 · cited 163× · PMID 37059508 · DOI 10.1016/s1474-4422(23)00080-7
Anti-inflammatory and Neuroprotective Agents in Clinical Trials for CNS Disease and Injury: Where Do We Go From Here?
Mallah K, Couch C, Borucki DM, Toutonji A, et al · · 2020 · cited 70× · PMID 33013859 · DOI 10.3389/fimmu.2020.02021
Cyclic Peptides in Pipeline: What Future for These Great Molecules?
Costa L, Sousa E, Fernandes C. · · 2023 · cited 50× · PMID 37513908 · DOI 10.3390/ph16070996
Treatment of Rare Inflammatory Kidney Diseases: Drugs Targeting the Terminal Complement Pathway.
Anliker-Ort M, Dingemanse J, van den Anker J, Kaufmann P. · · 2020 · cited 33× · PMID 33362783 · DOI 10.3389/fimmu.2020.599417
Emerging Role of C5 Complement Pathway in Peripheral Neuropathies: Current Treatments and Future Perspectives.
Giorgio C, Zippoli M, Cocchiaro P, Castelli V, et al · · 2021 · cited 29× · PMID 33917266 · DOI 10.3390/biomedicines9040399
Zilucoplan: First Approval.
Shirley M. · · 2024 · cited 21× · PMID 38093160 · DOI 10.1007/s40265-023-01977-3
Immunological perspectives on the pathogenesis, diagnosis, prevention and treatment of COVID-19.
Ni Y, Alu A, Lei H, Wang Y, et al · · 2021 · cited 20× · PMID 34766001 · DOI 10.1186/s43556-020-00015-y
Targeting autoimmune mechanisms by precision medicine in Myasthenia Gravis.
Cavalcante P, Mantegazza R, Antozzi C. · · 2024 · cited 19× · PMID 38903526 · DOI 10.3389/fimmu.2024.1404191

Verify or expand the search:

Other trials of zilucoplan (RA101495)

Trials testing the same drug.

NCT05514873 — An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With G · Phase 3 · completed
NCT04115293 — Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis · Phase 3 · completed
NCT03315130 — Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis · Phase 2 · completed

Other recruiting trials for Generalized Myasthenia Gravis

Currently open trials in the same condition.

NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab · Phase 4 · recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip · 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
NCT06967480 — Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis · recruiting

Other UCB Biopharma SRL trials

Trials by the same sponsor.

NCT07465289 — A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gr · Phase 3 · not yet recruiting
NCT07463521 — A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis · Phase 3 · not yet recruiting
NCT07277660 — A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Stu · Phase 2 · recruiting
NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu · Phase 1 · recruiting
NCT07286682 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants · Phase 1 · 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 NCT04225871 (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 UCB Biopharma SRL
Last refreshed: 27 February 2026

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/NCT04225871.

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