MoonLake Immunotherapeutics plans to submit an FDA Biologics License Application for Sonelokimab in hidradenitis suppurativa by the end of September following a positive pre-BLA meeting. The submission is supported by clinical trial data showing 43% of patients achieved high-level improvement by Week 12 in the Mira trial. The company is also expecting multiple Phase 3 data readouts throughout the year.
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07737730 |
A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA) |
NOT_YET_RECRUITING | |
| NCT07642622 |
Physical Activity Through Health Technology in Axial Spondyloarthritis |
RECRUITING | NA |
| NCT07290036 |
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults |
RECRUITING | PHASE1 |
| NCT07148414 |
A Study of SPY072 in Rheumatic Disease |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07087912 |
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases |
RECRUITING | PHASE4 |
| NCT06888193 |
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab) |
RECRUITING | PHASE1 |
| NCT06451588 |
Fecal Microbiota Transplantation in Axial Spondyloarthritis |
RECRUITING | PHASE2 |
| NCT04436640 |
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04159597 |
Expanded Access to Upadacitinib |
AVAILABLE | |
| NCT03965650 |
Video Coaching of Physical Activity in Axial Spondyloarthritis |
ACTIVE_NOT_RECRUITING | NA |
