KESIMPTA®▼ (ofatumumab) clinical studies

KESIMPTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.¹

ASCLEPIOS and ALITHIOS

The efficacy and safety profile of KESIMPTA was initially studied vs an oral active comparator, teriflunomide, in two identically designed Phase III studies: ASCLEPIOS I and II (N=1882).*^1,2

All patients who completed ASCLEPIOS I/II in the core period were eligible to enter ALITHIOS but could withdraw prior to treatment. The efficacy analysis set of ALITHIOS comprised all patients randomised to KESIMPTA or teriflunomide in ASCLEPIOS I/II, regardless of whether they completed/discontinued study treatment. In ALITHIOS, the safety analysis set comprised patients who received ≥1 dose of KESIMPTA in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS. ALITHIOS is an ongoing, open-label, extension study and was designed to assess the benefit-risk profile of KESIMPTA and its tolerability in RMS patients (N=1703); this is an ongoing study estimated to end in December 2027.^†3–5

View the interactive study design for ASCLEPIOS and ALITHIOS below. To see more information, click on the arrows or scroll down, as appropriate. 

*ASCLEPIOS I and II were randomised, double-blind, double-dummy, active-comparator controlled, parallel-group multicentre pivotal trials.^2
†ALITHIOS is an ongoing open-label, umbrella extension, Phase IIIb, single arm, multicentre, long-term study estimated to end in December 2027, evaluating the safety, tolerability and effectiveness of KESIMPTA (20 mg SC) in subjects with RMS.^4,5

ARR, annualised relapse rate; CDI, confirmed disability improvement; CDW, confirmed disability worsening; DMT, disease-modifying therapy; ECG, electrocardiogram; EDSS, expanded disability status scale; EOS, end of study; Gd, gadolinium; Gd+, gadolinium enhancing; MRI, magnetic resonance imaging; MS, multiple sclerosis; RMS, relapsing forms of multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SC, subcutaneous; SPMS, secondary progressive multiple sclerosis; W, week.

References

1. KESIMPTA (ofatumumab) Summary of Product Characteristics.

2. Hauser SL, et al. New Engl J Med 2020;383(6):546–557, and supplementary material.

3. Wiendl H, et al. American Academy of Neurology Annual Meeting, Denver, CO, USA; April 13–18, 2024, P9.010.

4. ClinicalTrials.gov. NCT03650114. Available at: https://clinicaltrials.gov/ct2/show/NCT03650114 [Accessed January 2025].

5. Hauser SL, et al. Mult Scler 2023;29(11–12):1452–1464.

6. O’Connor P, et al. Neurology 2016;86(10):920–930.

7. Bar-Or A, et al. Mult Scler 2022;28(6):910–924.

8. Kira JI, et al. Mult Scler 2022;28(8):1229–1238.

UK | January 2025 | 443372