UCLA announces participation in a Phase III trial evaluating tecovirimat for the treatment of monkeypox

UCLA’s Center for Clinical AIDS Research and Education (CARE) today announced its participation in the STOMP (Tecovirimat Study for Human Monkeypox Virus), or A5418, Phase 3, randomized, placebo-controlled, double-blind trial to assess safety and effectiveness Tecofermat for the treatment of monkeypox in humans. STOMP, led by the AIDS Clinical Trials Group (ACTG), is designed to learn as much as possible in a broad group of people with monkeypox.

A global outbreak of monkeypox emerged in the spring of 2022 and has since spread worldwide, with more than 56,000 cases in 103 countries and more than 21,000 cases in the United States. Monkeypox was first recognized in 1958 and has caused an increase in the number of infections annually in endemic countries. The current outbreak has been characterized by increased person-to-person transmission. Close contact during sexual activity is thought to play an important role in this outbreak. While most cases have so far been reported among men who have had sex with men, women and children have also been infected. There are currently no approved treatments for human monkeypox.

Tecovirimat (SIGA Technologies, Inc.) has been approved by the US Food and Drug Administration (FDA) for the treatment of smallpox, but it is not yet known whether it can effectively or safely treat monkeypox.

This multicenter trial will enroll more than 500 adults with monkeypox virus infection. Importantly, this trial will include people who are severely ill and those at risk for serious illness including pregnant and nursing women, children, and individuals with underlying immune deficiency and active inflammatory skin conditions who will receive open-label tekovirimat. Study participants with symptomatic monkeypox virus infection who do not meet the criteria for the open-label group will be randomly assigned to a two-to-one ratio to receive either tekovirimat or oral placebo for 14 days. Participants randomized to the double-blind study group who subsequently developed severe disease will be offered the option to switch to open-label tecovirimat, as will participants who reported persistent severe pain from monkeypox virus infection.

All STOMP participants will be followed up for at least eight weeks with a combination of virtual, in-person, and daily self-report visits to determine if those receiving tekovirimat recover more quickly compared to those receiving placebo. STOMP will also provide important data on the optimal doses and safety of tekovirimat in children and in pregnant and breast-feeding persons.

Individuals who have developed presumed or confirmed monkeypox infection (test positive within seven days) and begin experiencing symptoms within 13 days are eligible. The test will be provided by the study. Participants with presumed monkeypox virus infection who have not yet been tested are able to enroll as long as the test provided by the study is positive. Participants must also have at least one active skin lesion that has not yet crusted over, a lesion in the mouth, or proctitis (inflammation of the lining of the rectum).

The ACTG designed this study to give us as many insights as possible about whether and how tecovirimat works against monkeypox, including whether the virus is developing resistance to treatment. An important part of this design is the inclusion of children and pregnant women. The study will also evaluate the signs that might tell us the drug is working so that we can identify the most promising drugs in the future. In addition to addressing the current outbreak, this study has the potential to provide profound information on the treatment of individuals who contract monkeypox virus in endemic countries.”

Judith Currier, Chairman of the Board of Directors of the ACTG Group, holds a master’s degree, from UCLA

STOMP is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds ACTG. A list of participating sites can be found in the United States over here.

STOMP is led by Timothy Wilkin, MD, MSc, Weill Cornell Medicine and William Fisher, MD, University of North Carolina (UNC) and Jason Zucker, MD, Columbia University (Vice Presidents) and supported by Dr. Currier and Joseph J. Iron, MD, UNC (Co-Chair ACTG).

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