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A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants with Graves’ Disease

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526482-19-00
Enrollment
15
Registered
2026-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves’ Disease

Brief summary

Percentage of Participants who are Euthyroid and off Anti-Thyroid Drugs (ATD) at Week 24

Detailed description

Percentage of Participants who Have Down-Titrated to ≤ 50% of Their Baseline ATD and are Euthyroid at Week 12 and Week 24, Percentage of Participants who are Euthyroid at Week 12 and Week 24, Change From Baseline in Free Triiodothyronine (FT3), Change From Baseline in Free Thyroxine (FT4), Change From Baseline in Thyroid-Stimulating Hormone (TSH), Change From Baseline in ATD Levels, Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI), Felzartamab Serum Concentrations Over Time, Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab

Interventions

DRUGFelzartamab
DRUG0.9% Saline

Sponsors

Biogen Idec Research Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of Participants who are Euthyroid and off Anti-Thyroid Drugs (ATD) at Week 24—

Secondary

MeasureTime frame
Percentage of Participants who Have Down-Titrated to ≤ 50% of Their Baseline ATD and are Euthyroid at Week 12 and Week 24, Percentage of Participants who are Euthyroid at Week 12 and Week 24, Change From Baseline in Free Triiodothyronine (FT3), Change From Baseline in Free Thyroxine (FT4), Change From Baseline in Thyroid-Stimulating Hormone (TSH), Change From Baseline in ATD Levels, Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI), Felzartamab Serum Concentrations Over Time, Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 16, 2026