KESIMPTA®▼ (ofatumumab) Clinical studies

ASCLEPIOS and ALITHIOS

The efficacy 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

A total of 70% of the patients from ASCLEPIOS trials (n=1,367) were then enrolled into an ongoing, open-label, extension study: ALITHIOS (n=1703). ALITHIOS was designed to assess the benefit-risk profile of KESIMPTA and its tolerability in RMS patients for up to 5 years.^2,3

View the interactive study design for ASCLEPIOS and ALITHIOS below. You can click on the plus signs for more information. 

*ALITHIOS is an ongoing open-label, umbrella extension, Phase IIIb, single arm, multicentre, long-term study (up to 5 years), evaluating the safety, tolerability and effectiveness of KESIMPTA (20 mg SC) in subjects with RMS.
^†The initial dosing period consists of 20 mg SC doses at Weeks 0, 1 and 2.
^‡ASCLEPIOS was a Phase III, 12-week, open-label, parallel-group study to demonstrate the pharmacokinetic bioequivalence of KESIMPTA injected by pre-filled syringe vs auto-injector device.⁷ APOLITOS, was a Phase III, 24-week, randomised, double-blind, placebo-controlled, parallel-group, multicentre study evaluating the efficacy, safety and tolerability, and pharmacokinetics of KESIMPTA in patients with RMS.⁸

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

References

1. Hauser SL, et al. New Engl J Med 2020;383(6):546–557, and supplementary material.
2. Hauser SL, et al. Oral presentation S14.004 presented at the American Academy of Neurology (AAN). April 2022.
3. Clinicaltrials.gov. NCT03650114. Available at: https://clinicaltrials.gov/ct2/show/NCT03650114 [Accessed January 2023].
4. Hauser SL, et al. New Engl J Med 2020;383(6):546–557, and supplementary material.
5. KESIMPTA (ofatumumab) Summary of Product Characteristics, Great Britain; July 2022.
6. KESIMPTA (ofatumumab) Summary of Product Characteristics, Northern Ireland; July 2022.
7. Clinicaltrials.gov.  NCT03560739. Available at: https://clinicaltrials.gov/ct2/show/NCT03560739 [Accessed January 2023].
8. Clinicaltrials.gov. NCT03249714. Available at: https://clinicaltrials.gov/ct2/show/NCT03249714 [Accessed January 2023].
9. O’Connor P, et al. Neurology 2016;86(10):920–930.