Trial Outcomes & Findings for Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis (NCT NCT01111305)

NCT ID: NCT01111305

Last Updated: 2022-01-27

Results Overview

Peak eosinophil count during the first 7 days of treatment as a percent of the baseline count

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: during the first 7 days of DEC treatment
• Results posted on: 2022-01-27

Participant Flow

31 subjects were enrolled on the screening phase of this protocol, of which 13 had Loa loa infection. Of these 13, 3 were excluded for Loa loa microfilarial loads that were too high, 1 could not comply with the trial time points, and one was lost to followup. This left 8 subjects who were enrolled on the treatment portion of the study.

Participant milestones

Measure	Reslizumab Reslizumab Diethylcarbamazine	Placebo Placebo Diethylcarbamazine
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis

Baseline characteristics by cohort

Measure	Reslizumab n=4 Participants Reslizumab Diethylcarbamazine	Placebo n=4 Participants Placebo Diethylcarbamazine	Total n=8 Participants Total of all reporting groups
Age, Continuous	36 years n=93 Participants	29 years n=4 Participants	31.5 years n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	4 participants n=93 Participants	4 participants n=4 Participants	8 participants n=27 Participants
Loa loa microfilarial level	212 mf/mL n=93 Participants	357 mf/mL n=4 Participants	275 mf/mL n=27 Participants
Absolute eosinophil count	1350 cells/microliter n=93 Participants	710 cells/microliter n=4 Participants	980 cells/microliter n=27 Participants

PRIMARY outcome

Timeframe: during the first 7 days of DEC treatment

Population: Subjects who received diethylcarbamazine treatment

Peak eosinophil count during the first 7 days of treatment as a percent of the baseline count

Outcome measures

Measure	Reslizumab + DEC n=4 Participants Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Reslizumab Diethylcarbamazine	Placebo + DEC n=4 Participants Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Diethylcarbamazine Placebo
Peak Eosinophil Count Post-treatment	61 percent of baseline eosinophil count Interval 42.7 to 104.0	245.6 percent of baseline eosinophil count Interval 175.0 to 372.0

SECONDARY outcome

Timeframe: 7 days following initiation of DEC treatment

Population: Subjects who received DEC treatment

Adverse events during the first week of DEC treatment

Outcome measures

Measure	Reslizumab + DEC n=4 Participants Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Reslizumab Diethylcarbamazine	Placebo + DEC n=4 Participants Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Diethylcarbamazine Placebo
Frequency of AE's	29 adverse events	28 adverse events

SECONDARY outcome

Timeframe: one week

serum eosinophil granule protein levels on day 7 measured as % baseline

Outcome measures

Measure	Reslizumab + DEC n=4 Participants Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Reslizumab Diethylcarbamazine	Placebo + DEC n=4 Participants Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Diethylcarbamazine Placebo
Markers of Eosinophil Activation % day 0 EDN at day 7	115 % change Interval 101.0 to 132.0	377 % change Interval 163.0 to 634.0
Markers of Eosinophil Activation % day 0 EPO at day 7	138 % change Interval 92.0 to 161.0	203 % change Interval 82.0 to 344.0

SECONDARY outcome

Timeframe: 3, 7, and 28 days after initiation of treatment with DEC

Outcome measures

Measure	Reslizumab + DEC n=4 Participants Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Reslizumab Diethylcarbamazine	Placebo + DEC n=4 Participants Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Diethylcarbamazine Placebo
Proportion of Subjects Who Clear Blood Microfilariae 3 days	2 Participants	2 Participants
Proportion of Subjects Who Clear Blood Microfilariae 7 days	4 Participants	4 Participants
Proportion of Subjects Who Clear Blood Microfilariae 28 days	4 Participants	4 Participants

Adverse Events

Reslizumab + DEC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo + DEC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Reslizumab + DEC n=4 participants at risk Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Reslizumab Diethylcarbamazine	Placebo + DEC n=4 participants at risk Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days Diethylcarbamazine Placebo
General disorders Fatigue	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	75.0% 3/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Gastrointestinal disorders Nausea	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
General disorders Headache	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Skin and subcutaneous tissue disorders Calabar swelling	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	75.0% 3/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Gastrointestinal disorders Abdominal Pain	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Investigations LDH increased	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Investigations ALT increased	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Investigations AST increased	75.0% 3/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Investigations Bilirubin increased	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Investigations CPK increased	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
Investigations Hematuria	50.0% 2/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.	25.0% 1/4 • 7 days A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.

Additional Information

Dr. Amy Klion

NIAID/NIH

Phone: 301-435-8903

Email: aklion@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place