Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults with Moderately to Severely Active Rheumatologic Disease

Conditions

Moderately to Severely Active Rheumatologic Disease

Brief summary

RA Substudy: Change from baseline in DAS28-CRP at Week 12. axSpA Substudy: Change in ASDAS from baseline to Week 16. PsA Substudy: Proportion of participants who achieve an ACR20 response at Week 16.

Detailed description

RA Substudy: Proportion of participants who achieve an ACR20 response at Week 12. axSpA Substudy: Proportion of participants who achieve an ASAS40 response at Week 16. PsA Substudy: Change in DAPSA from baseline to Week 16., RA Substudy: PK concentration through Week 12. axSpA Substudy: PK concentration through Week 16. PsA Substudy: PK concentration through Week 16., RA Substudy: The proportion of participants with ADA through Week 12. axSpA Substudy: The proportion of participants with ADA through Week 16. PsA Substudy: The proportion of participants with ADA through Week 16., RA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 12 and through the end of study. axSpA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 16 and through the end of study. PsA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation at Week 16 and through the end of study.

Related papers

No related papers found yet.

Interventions

DRUGSPYPBO-101 Placebo to SPY072

DRUGSPY072

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
RA Substudy: Change from baseline in DAS28-CRP at Week 12. axSpA Substudy: Change in ASDAS from baseline to Week 16. PsA Substudy: Proportion of participants who achieve an ACR20 response at Week 16.	—

Secondary

Measure	Time frame
RA Substudy: Proportion of participants who achieve an ACR20 response at Week 12. axSpA Substudy: Proportion of participants who achieve an ASAS40 response at Week 16. PsA Substudy: Change in DAPSA from baseline to Week 16., RA Substudy: PK concentration through Week 12. axSpA Substudy: PK concentration through Week 16. PsA Substudy: PK concentration through Week 16., RA Substudy: The proportion of participants with ADA through Week 12. axSpA Substudy: The proportion of participants with ADA through Week 16. PsA Substudy: The proportion of participants with ADA through Week 16., RA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 12 and through the end of study. axSpA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 16 and through the end of study. PsA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation at Week 16 and through the end of study.	—

Measure

Time frame

RA Substudy: Proportion of participants who achieve an ACR20 response at Week 12. axSpA Substudy: Proportion of participants who achieve an ASAS40 response at Week 16. PsA Substudy: Change in DAPSA from baseline to Week 16., RA Substudy: PK concentration through Week 12. axSpA Substudy: PK concentration through Week 16. PsA Substudy: PK concentration through Week 16., RA Substudy: The proportion of participants with ADA through Week 12. axSpA Substudy: The proportion of participants with ADA through Week 16. PsA Substudy: The proportion of participants with ADA through Week 16., RA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 12 and through the end of study. axSpA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation through Week 16 and through the end of study. PsA Substudy: Incidence of TEAEs, SAEs, AESIs, and AEs leading to IP discontinuation at Week 16 and through the end of study.

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Countries

Bulgaria, Czechia, Poland, Spain

Outcome results

None listed