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

Age range18 Years – 55 Years

SexALL

See this in plain English?

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

✓. 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:

✕. 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.
✕. Any clinically important illness, including but not limited to a history of clinically significant chronic respiratory disease (eg, chronic obstructive pulmonary disease \[COPD\] or asthma), medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product.
✕. Participants participate in another clinical study. There will be a need for washout with 5 half-lives depending on the study treatment or 30 days, whichever is longer.
✕. Use of anti-cancer, anti-transplant rejection, or immunomodulatory biological drug or kinase inhibitor (e.g., tocilizumab, sarilumab) or Janus kinase inhibitors (within 30 days of enrollment or 5 times the half-life \[whichever is longer\]).
✕. Chronic corticosteroids use equivalent to daily oral prednisone \>10 mg per day (10 mg oral prednisone every other day is allowed).

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

NCT IDNCT06040346

SponsorJiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

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

✓. 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:

✕. 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.
✕. Any clinically important illness, including but not limited to a history of clinically significant chronic respiratory disease (eg, chronic obstructive pulmonary disease \[COPD\] or asthma), medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product.
✕. Participants participate in another clinical study. There will be a need for washout with 5 half-lives depending on the study treatment or 30 days, whichever is longer.
✕. Use of anti-cancer, anti-transplant rejection, or immunomodulatory biological drug or kinase inhibitor (e.g., tocilizumab, sarilumab) or Janus kinase inhibitors (within 30 days of enrollment or 5 times the half-life \[whichever is longer\]).
✕. Chronic corticosteroids use equivalent to daily oral prednisone \>10 mg per day (10 mg oral prednisone every other day is allowed).