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US-RZ-2400024

Study design

STUDY DESIGN

RYSTIGGO was
studied in the
Phase 3

MycarinG
clinical trial1,2

Anti-AChR Ab+ and anti-MuSK Ab+ gMG

patients were enrolled in MycarinG1

Change from baseline in MG‑ADL total score

at Week 6 (Day 43) was the primary endpoint1

Anti-AChR Ab+ and anti-MuSK Ab+ gMG

adult patients were enrolled in MycarinG1

Change from baseline in MG‑ADL

total score at Week 6 (Day 43) was the primary endpoint1

MycarinG CLINICAL TRIAL

Efficacy, safety, and tolerability were evaluated in a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of adult patients with mild to severe gMG1,2

Clinical Trial Design.
Clinical Trial Design.

This trial assessed 2 doses of RYSTIGGO, 7 mg/kg (n=66) and 10 mg/kg (n=67), vs placebo (n=67). All patients continued on current therapies.1,2

Inclusion Criteria1,2

Adult patients enrolled in the study met the following criteria:

  • Presence of autoantibodies against AChR or MuSK
  • MGFA Clinical Classification Class II to IVa
  • MG-ADL total score of at least 3 (with ≥3 points from non-ocular symptoms)
  • On stable dose of MG therapy prior to screening that included AChE inhibitors, steroids, or other NSISTs, either in combination or alone
  • Serum IgG levels of at least 5.5 g/L
  • QMG score of at least 11

Baseline characteristics2,3

 
RYSTIGGO 7 mg/kg (n=66)
RYSTIGGO 10 mg/kg (n=67)
Placebo (n=67)
Mean age in years
53
52
50
Median duration of disease in years
5.3
5.7
6.8
Gender distribution, % female
59%
52%
70%
Race, % White
62%
73%
69%
Race, % Asian
14%
10%
7%
Race, % Black
0%
6%
1%
Race, % American Indian or Alaska Native
0%
0%
0%
Ethnicity, % Hispanic or Latino
8%
5%
8%
Mean MG-ADL score at baseline
8.4
8.1
8.4
Mean QMG score at baseline
15.4
15.6
15.8
Anti-AChR Ab+, n (%)
60 (91%)*
60 (90%)
59 (88%)*
Anti-MuSK Ab+, n (%)
5 (8%)
8 (12%)
8 (12%)
MGFA Class IIa, n (%)
13 (20%)
13 (19%)
11 (16%)
MGFA Class IIb, n (%)
16 (24%)
13 (19%)
12 (18%)
MGFA Class IIIa, n (%)
21 (32%)
26 (39%)
28 (42%)
MGFA Class IIIb, n (%)
13 (20%)
13 (19%)
13 (19%)
MGFA Class IVa, n (%)
3 (5%)
2 (3%)
2 (3%)
MGFA Class IVb, n (%)
0 (0%)
0 (0%)
1 (1%)
Treatment with acetylcholinesterase inhibitors, n (%)
55 (83%)
57 (85%)
60 (90%)
Treatment with corticosteroids, n (%)
43 (65%)
48 (72%)
38 (57%)
Treatment with non-steroidal immunosuppressive therapies (NSISTs), n (%)
32 (48%)
38 (57%)
33 (49%)

*Includes one patient who had unknown AChR and MuSK autoantibody status.2

Includes one patient who had positive AChR and MuSK autoantibody status.2

Patient was classified as MGFA class III at screening, but class IVb at baseline.2

Ab+=antibody positive; AChE=acetylcholinesterase; AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; IgG=immunoglobulin G; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; MuSK=muscle-specific tyrosine kinase; NSISTs=non-steroidal immunosuppressive therapies; QMG=Quantitative Myasthenia Gravis.

References:

  1. RYSTIGGO [Prescribing Information]. Smyrna, GA: UCB, Inc.
  2. Bril V, Drużdż A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394. doi:10.1016/S1474-4422(23)00077-7
  3. Data on file. UCB Inc., Smyrna, GA.