RPH-035 in Multiple Sclerosis, Secondary Progressive: NCT07597668 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Active, not recruiting
Recruitment status
180
Planned enrollment
2026-06-02
Primary-completion proxy
Executive view
NCT07597668 evaluates RPH-035 in Multiple Sclerosis, Secondary Progressive. The disclosed sponsor is R-Pharm US LLC, the design is Interventional, and the geographic footprint is Russia. The first listed primary endpoint is The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab, assessed over Day 14 to Day 169.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07597668 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Multiple Sclerosis, Secondary Progressive landscape. Drug & Asset MCP drug_fetch was queried for RPH-035, while Company & Deal Intelligence MCP organization_fetch was queried for R-Pharm US LLC.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07597668 | RPH-035 | Phase 1 / Active, not recruiting | R-Pharm US LLC | Russia | The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab Day 14 to Day 169 | 2026-06-02 |
| NCT07756268 | SYS-6020 | Phase 1/2 / Not yet recruiting | Huazhong University of Science Tongji Hospital, Tongji Medical College | China | Safety and tolerability From informed consent through Month 24 | 2029-02-07 |
| NCT07748637 | GT802 (Vivacta Biotechnology (Shanghai) Co., Ltd.) | Early Phase 1 / Not yet recruiting | Sponsor not reported | China | Proportion of participants experiencing dose limiting toxicity 28 days | 2031-07-30 |
| NCT07749157 | RO7845860 (F. Hoffmann-La Roche Ltd.) | Phase 1 / Not yet recruiting | Hoffmann-La Roche, Inc. | Geography not reported | Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs) From Baseline up to approximately Week 96 | 2031-02-28 |
| ACTRN12626000924358 | Docosahexaenoic acid | Not Applicable / Not yet recruiting | Sponsor not reported | Australia | Timing not reported |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07597668 is a Phase 1, active, not recruiting study with 180 planned participants. Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment.
The primary endpoint is “The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab” over “Day 14 to Day 169.” The retrieved endpoint description is: The area under the concentration-time pharmacokinetic curve of ocrelizumab after the second (single) administration, truncated at Day 169 (AUC (14-169 days)).
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 180 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Ocrelizumab as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
4 recent result records were selected as contextual evidence for Multiple Sclerosis, Secondary Progressive. These records do not establish direct evidence for NCT07597668 unless the registration number matches.
A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients…
Phase 3; n=236; Serum Ocrelizumab Area Under the Concentration-Time Curve Over the First 12 Weeks (AUCW1-12) After SC Administration(Mean): Geometric Mean Ratio = 1.2851(90% CI, 1.2258 - 1.3473); Serum Ocrelizumab Area Under the Concentration-Time Curve Over the First 12 Weeks (AUCW1-12) After SC Administration(Mean) = 3500 micrograms/milliliters*day (µg/mL*day) (Standard Deviation, 914) Source: https://clinicaltrials.gov/ct2/show/results/NCT05232825
Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
Phase 2; n=75; Percentage of Participants With Protective Antibody Titers After Vaccination = 93.5 percentage of pts ; Percentage of Participants With Protective Antibody Titers After Vaccination = 93.5 percentage of pts Source: https://clinicaltrials.gov/ct2/show/results/NCT00505063
A Phase IIIB Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary P…
Phase 3; n=769; Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)(Median) = 158.7 weeks (95% Confidence Interval, 120.0 - NA); Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)(Median) = 169.0 weeks (95% Confidence Interval, 144.1 - NA) Source: https://clinicaltrials.gov/ct2/show/results/NCT04548999
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
No exact Drug & Asset MCP profile was returned for the protocol wording “RPH-035.” The report therefore avoids inferring modality, target or global development stage from the name alone.
No exact Company & Deal Intelligence profile was returned for R-Pharm US LLC. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether RPH-035 is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07597668
Protocol source: https://clinicaltrials.gov/study/NCT07597668
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.
RPH-035 in Multiple Sclerosis, Secondary Progressive is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab and 2026-06-02 the leading decision points.
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