Mass General Brigham sites announce their participation in the Phase 3 trial for the treatment of monkeypox

Mass General Brigham sites announce their participation in the Phase 3 trial for the treatment of monkeypox

Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH), founding members of Mass General Brigham, today announced their participation in STOMP (Study of Tecovirimat for Human Monkeypox Virus), a Phase 3, randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Tecovirimat (TPOXX) for the treatment of human monkeypox. STOMP, led by the AIDS Clinical Trials Group (ACTG), will collect data from a broad population of people with monkeypox to determine whether participants who receive tecovirimat heal faster and experience less pain than those who take placebo.

We need studies like STOMP to know whether a drug works effectively and whether it is the best treatment for our patients. Randomized, double-blind clinical trials provide us with important information to improve clinical care, and people living in the Greater Boston area who have monkeypox have the opportunity to make a big difference by participating in this trial.”

Elizabeth (Libby) Hohmann, MD, MGH Site Director, Division of Infectious Diseases at MGH

“This study will help us understand whether TPOXX makes a difference in a patient's disease progression and what aspects of the disease it is effective against,” said BWH site manager Jennifer Manne-Goehler, MD, ScD, of the Division of Infectious Diseases at BWH. "Does it promote faster healing? Does it lead to less viral shedding? Does it reduce rare but serious complications of monkeypox? These are pressing questions that only a study like this can answer for us."

A global outbreak of monkeypox occurred in the spring of 2022 and has since spread throughout the world, with more than 56,000 cases in 103 countries and more than 21,000 cases in the United States, including 420 in Massachusetts.

Tecovirimat (manufactured by SIGA Technologies, Inc.) is approved by the U.S. Food and Drug Administration (FDA) to treat smallpox, but it is not yet known whether it can effectively or safely treat monkeypox. The drug was used to treat some patients during the current monkeypox outbreak under the Investigational New Drug Protocol (EA-IND), sometimes called compassionate use.

This multicenter study will enroll more than 500 adults with monkeypox virus infection. Importantly, this study includes people with serious illnesses and people at high risk of serious illnesses, including pregnant and breastfeeding people, children, and those with underlying immunodeficiency and active inflammatory skin diseases. This high-risk group will all receive open-label Tecovirimat. Study participants with symptomatic monkeypox virus infection who do not meet criteria for the open cohort will be randomly assigned in a 2 to 1 ratio to receive either tecovirimat or placebo orally for 14 days. Participants who are randomized to the study's double-blind cohort and later develop severe disease will be offered the opportunity to switch to open-label Tecovirimat, as will participants who report persistent severe pain due to monkeypox virus infection.

"This study is designed to focus on the needs of the patient. If a person progresses or experiences more severe symptoms, we have the option to give them TPOXX without randomization," Manne-Goehler said.

All STOMP participants will be followed for at least eight weeks through a combination of virtual and in-person visits, as well as daily self-reports, to determine whether patients receiving tecovirimat heal more quickly compared to those receiving a placebo. STOMP will also provide important data on the optimal dosage and safety of tecovirimat in children and pregnant and breastfeeding people.

Persons who have a suspected or confirmed monkeypox infection (positive test within seven days) and who first experience symptoms within 13 days are eligible to participate. The investigation is carried out through the study. Participants with a suspected monkeypox virus infection who have not yet been tested may enroll as long as their study-provided test is positive. Participants must also have at least one active skin lesion that has not yet crusted over, one oral lesion, or proctitis (inflammation of the rectal lining).

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

STOMP is led by Timothy Wilkin, MD, MPH, Weill Cornell Medicine, William Fischer, MD, University of North Carolina (UNC), and Jason Zucker, MD, Columbia University (Vice Chair) and supported by Judith Currier, MD. MSc, UCLA, and Joseph J. Eron, MD, UNC (ACTG co-chair).

Source:

Massachusetts General Hospital

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