Phase 2
N=8
Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis
Loiasis
Bottom Line
View on ClinicalTrials.gov: NCT01111305 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Peak Eosinophil Count Post-treatment — 61; 245.6 percent of baseline eosinophil count — p=0.028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Reslizumab (Drug); Diethylcarbamazine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Eosinophil Count Post-treatment |
61; 245.6 | 0.028 sig |
| SECONDARY Frequency of AE's |
29; 28 | — |
| SECONDARY Markers of Eosinophil Activation |
115; 377; 138; 203 | — |
| SECONDARY Proportion of Subjects Who Clear Blood Microfilariae |
2; 2; 4; 4; 4; 4 | — |
Summary
Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the development of severe adverse reactions that are correlated with the number of circulating microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. This randomized, placebo-controlled, double-blind pilot study (conducted at the NIH Clinical Center) will assess whether and to what extent the administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3 times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on microfilarial clearance.
Eligibility Criteria
- INCLUSION CRITERIA: (Screening)
A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply:
- Between 18 and 65 years of age
- Residence in or travel to a Loa-endemic region for greater than 1 month
EXCLUSION CRITERIA: (Screening)
A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply:
- Known to be pregnant
- Known to be HIV-positive
INCLUSION CRITERIA: (Interventional Study)
A subject will be eligible for participation in the interventional portion of the study only if all of the following criteria apply:
- The subject has documented loiasis with 0-5000 microfilariae/mL blood.
- The subject agrees to storage of samples for study
- A female subject is eligible for this study if she is any of the following:
- Not pregnant or breast-feeding.
- Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)
- Of childbearing potential but agrees to practice effective contraception* or abstinence for 3 months after administration of the investigational study drug (reslizumab or placebo)
- NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female subject s entry into the study and is the sole sexual partner for the female subject; 2) implants of levonorgestrel; 3) injectable progestogen, an intrauterine device with a documented failure rate of less than 1percent; 4) oral contraceptives; and 5) double barrier methods including diaphragm or condom with a spermicide.
EXCLUSION CRITERIA: (Interventional Study)
A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment:
- The subject tests positive for HIV infection or has any other known immunodeficiency.
- The subject has a concomitant active infection with Onchocerca volvulus.
- The subject has used any other investigational agent within the past 30 days.
- The subject has used immunosuppressive agents (as listed in section 8.1) within the past 30 days.
- The subject has a history of allergic reaction to any antibody therapy or to DEC.
- The subject has chronic kidney or liver disease.
- The subject has any condition that, in the Investigator s opinion, places the subject at undue risk by participating in the study.
Data sourced from ClinicalTrials.gov (NCT01111305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.