Table 3.
Ongoing clinical trials of SRK
| Name/number | Design | Population prior treatment | Treatment arms | Primary endpoint | Study status | Estimated completion date |
|---|---|---|---|---|---|---|
| SIRROUND-D71 | Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study | 1,670 RA patients with active disease despite DMARD therapy | Group 1: SRK 100 mg SC q2w through week 52, or SRK 50 mg SC q4w through week 104, or placebo Group 2: SRK 100 mg SC q2w through week 104 Group 3: SRK 50 mg SC q4w through week 104, or placebo |
Proportion of patients with ACR20 response, and change from baseline in vdH score | Active, nonrecruiting | January 2017 |
| SIRROUND-H72 | Phase III, multicenter, randomized, double-blind, parallel group study | 559 RA patients with active disease | Group 1: adalimumab 40 mg q2w through week 52 Group 2: SRK 100 mg q2w through week 52 Group 3: SRK 50 ng q4w through week 52 |
Change from baseline in DAS28-ESR, and percentage of ACR50 response | Active, nonrecruiting | August 2016 |
| SIRROUND-T73 | Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study | 878 RA patients with active disease despite anti-TNF-α therapy | Group 1: SRK 100 mg SC q2w through week 23, or SRK 50 mg SC q4w through week 52, or placebo Group 2: SRK 100 mg SC q2w through week 52 Group 3: SRK 50 mg SC q4w through week 52, or placebo |
Proportion of patients with ACR20 response | Completed | January 2016 |
| SIRROUND-M74 | Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study | 121 RA patients with active disease unresponsive to methotrexate or sulfasalazine | Group 1: SRK 100 mg SC q2w through week 52 Group 2: SRK 50 mg SC q4w through week 52, or placebo |
Proportion of patients with AEs | Completed | March 2015 |
| SIRROUND-LTE75 | Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study | RA patients completing SIRROUND-D and SIRROUND-T studies | Group 1: SRK 100 mg SC q2w through week 156 (SIRROUND-D participants) and 208 (SIRROUND-T participants) Group 2: SRK 50 mg SC q4w through week 156 (SIRROUND-D participants) and 208 (SIRROUND-T participants) |
Proportion of patients with cardiovascular serious AEs, malignancies, serious infections, or gastrointestinal perforations | Enrolling by invitation | April 2020 |
| SIRRESTA85 | Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study | Estimated enrollment of 204 GCA patients under prednisone treatment | SRK 100 mg q2w SC, or SRK 50 mg q4w SC through week 52 (Part A, double-blind treatment phase) and week 104 (Part B, long-term extension phase), or placebo | Proportion of patients in sustained remission at week 52 | Active, recruiting | May 2020 |
| NCT0247328988 | Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel study | Estimated enrollment of 192 patients with major depressive disorder under treatment with a monoaminergic antidepressant | Group 1: SRK 50 mg SC on day 1, 28, and 56 Group 2: placebo |
Change from baseline in HDRS17 at week 12 | Active, recruiting | October 2017 |
Abbreviations: RA, rheumatoid arthritis; SRK, sirukumab; SC, subcutaneously; q2w, every 2 weeks; q4w, every 4 weeks; ACR, American College of Rheumatology; DAS28-ESR, disease activity score in 28 joints using erythrocyte sedimentation rate; vdH, van der Heijde score; AEs, adverse events; TNF-α, tumor necrosis factor-α; HDRS17, Hamilton Depression Rating Scale; GCA, giant-cell arteritis.