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Clinical trials

Roche posts Phase 3 results for obinutuzumab in childhood nephrotic syndrome

Hoffmann-La Roche posted results on October 14, 2026 for its INShore trial of obinutuzumab against mycophenolate mofetil. The record lists sustained complete remission at Week 52 in 95.5% of 44 participants on obinutuzumab and 73.2% of 41 on mycophenolate mofetil.

By The Priority Review desk

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Hoffmann-La Roche has posted results for a Phase 3 trial of obinutuzumab in children and young adults with frequently relapsing or steroid-dependent nephrotic syndrome. The trial registry record for NCT05627557 lists the results as first posted on October 14, 2026. For the primary outcome, the record lists sustained complete remission at Week 52 in 95.5% of the 44 participants on obinutuzumab and 73.2% of the 41 on mycophenolate mofetil (MMF).

Remission and relapse-free measures in the INShore record Obinutuzumab (n = 44) against mycophenolate mofetil (n = 41) unless noted 0% 20% 40% 60% 80% 100% Percentage of participants Obinutuzumab sustained remission, Week 52 95.5% Mycophenolate mofetil sustained remission, Week 52 73.2% Obinutuzumab sustained remission, Week 76 (n = 20) 80.0% Mycophenolate mofetil sustained remission, Week 76 (n = 21) 61.9% Obinutuzumab relapse-free probability, Week 52 90.91% Mycophenolate mofetil relapse-free probability, Week 52 70.73% The Week 76 comparison has a p-value of 0.1399 in the record. The record states percentages were rounded off. Trial registry record NCT05627557. The Priority Review.
Remission and relapse-free measures in the INShore record Obinutuzumab (n = 44) against mycophenolate mofetil (n = 41) unless noted 0% 20% 40% 60% 80% 100% Percentage of participants Obinutuzumab sustained remission, Week 52 95.5% Mycophenolate mofetil sustained remission, Week 52 73.2% Obinutuzumab sustained remission, Week 76 (n = 20) 80.0% Mycophenolate mofetil sustained remission, Week 76 (n = 21) 61.9% Obinutuzumab relapse-free probability, Week 52 90.91% Mycophenolate mofetil relapse-free probability, Week 52 70.73% The Week 76 comparison has a p-value of 0.1399 in the record. The record states percentages were rounded off. Trial registry record NCT05627557. The Priority Review.

What the record says about the design

The record calls the study INShore and describes it as a Phase III, international, multicenter, randomized, open-label study. It compares obinutuzumab with MMF in participants aged 2 to 25 years who had frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Participants had to be in complete remission at screening, with at least one relapse in the 6 months before screening.

Participants were randomized 1:1. The obinutuzumab group received 1000 milligrams (or 20 mg/kg for participants under 45 kg) by intravenous infusion on Days 1, 15, 168 (Week 24) and 182 (Week 26). The MMF group took 600 mg/m^2 by mouth twice a day to Week 52. Prednisone was tapered in both groups.

The record says 85 participants took part at 32 investigative sites across 9 countries: 44 on obinutuzumab and 41 on MMF. Mean age was 10.4 years in the obinutuzumab group and 9.3 years in the MMF group. The record's status field lists the study as completed, while its recruitment note says the study is still ongoing and that final data will be reported later.

The primary outcome

The record lists one primary outcome, sustained complete remission at Week 52. It defines this as a first-morning urine protein-to-creatinine ratio of 0.2 g/g or lower at Week 52, with no relapse after Week 8 and no other listed event such as rescue therapy or death; the record states that stopping study treatment for any reason does not by itself count against remission. The record lists 95.5% for obinutuzumab (95% confidence interval 89.30 to 100.00) and 73.2% for MMF (95% confidence interval 59.61 to 86.73).

The record lists an adjusted difference of 23.36 (95% confidence interval 6.85 to 38.90) and a p-value of 0.0031. It says this was test 1 of 10 in a fixed-sequence plan to control type I error.

Secondary outcomes in the record

Under the same fixed sequence, the record lists a hazard ratio of 0.25 (95% confidence interval 0.08 to 0.75, p = 0.0074) for overall relapse-free survival. The median was not estimable for obinutuzumab and 93.4 weeks for MMF. The median cumulative corticosteroid dose to Week 52 was 10.07 mg/kg on obinutuzumab and 18.92 mg/kg on MMF (p = 0.0391). Relapses were 0.09 per year on obinutuzumab and 0.63 on MMF, with an adjusted rate ratio of 0.07 (p = 0.0015).

At Week 76, the record lists sustained complete remission in 80.0% of 20 participants on obinutuzumab and 61.9% of 21 on MMF. The p-value was 0.1399, the first test in the sequence to miss significance. The record marks the p-values for later outcomes as nominal because the hierarchical testing stops at the first outcome that is not significant. Those include a Week 52 relapse-free probability of 90.91% against 70.73% (p = 0.0153) and edema-associated relapse in 2.3% against 14.6% (p = 0.0359).

Safety counts in the record

The record lists no deaths in either group. It lists serious adverse events in 7 of 44 participants on obinutuzumab and 3 of 41 on MMF. Other adverse events above the reporting threshold of 5 were listed in 42 of 44 and 34 of 41. The record's recruitment note says data collection is still ongoing, and the figures here are a sponsor report posted as summary data in the registry.

Sources