Active — Not RecruitingPhase 2

Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed with Plasmodium Falciparum

Kenya60 participantsStarted 2024-04-26

Plain-language summary

This phase 2a open-label study to assess Meplazumab in adult patients diagnosed with Plasmodium falciparum

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability to provide informed consent signed by the study participant or legally authorized representative
. Adults 18 to 55 years at the time of signing the informed consent form (ICF)
. Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP), as defined in Section 10.4.
. Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Section 10.4.
. BMI ≥18 to ≤30 kg/m2
. Mono-infection with P. falciparum documented by:

Exclusion criteria

. Presence of severe malaria (as defined by World Health Organization Guidelines for Malaria 16 February 2021).
. Antimalarial treatment (alone or in combination) during the following periods before Screening:
. Previous participation in any malaria vaccine study or received malaria vaccine within 3 months of Screening Visit.
. Known allergy to any study medication, including allergy to any component of protocol prescribed rescue treatment i.e., country-specific ACT regimen.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Number of participants with Drug-related SAE, All-cause SAE, Drug-related AESI, All-cause AESI.

Timeframe: up to 26 weeks

The Number of Participants discontinuation/ withdrawals due to AE

Timeframe: up to 26 weeks

Trial details

NCT IDNCT06040346

SponsorJiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08

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