Trial · NCT01111305

Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis

NCT01111305, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2017-06-01

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis. Trials, record NCT01111305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01111305

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis
NCT number: NCT01111305
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Loiasis
Interventions: Reslizumab, Diethylcarbamazine, Placebo
First posted: 2010-04-27
Last updated: 2022-01-27
Results first posted: 2017-06-01

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Peak Eosinophil Count Post-treatment	during the first 7 days of DEC treatment	Peak eosinophil count during the first 7 days of treatment as a percent of the baseline count
Secondary	Frequency of AE's	7 days following initiation of DEC treatment	Adverse events during the first week of DEC treatment
Secondary	Markers of Eosinophil Activation	one week	serum eosinophil granule protein levels on day 7 measured as % baseline
Secondary	Proportion of Subjects Who Clear Blood Microfilariae	3, 7, and 28 days after initiation of treatment with DEC

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Peak Eosinophil Count Post-treatment	during the first 7 days of DEC treatment	Subjects who received diethylcarbamazine treatment	percent of baseline eosinophil count	GEOMETRIC_MEAN
SECONDARY	Frequency of AE's	7 days following initiation of DEC treatment	Subjects who received DEC treatment	adverse events	NUMBER
SECONDARY	Markers of Eosinophil Activation	one week		% change	GEOMETRIC_MEAN
SECONDARY	Proportion of Subjects Who Clear Blood Microfilariae	3, 7, and 28 days after initiation of treatment with DEC		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Peak Eosinophil Count Post-treatment	Reslizumab + DEC		61	Full Range 42.7 to 104	percent of baseline eosinophil count
Peak Eosinophil Count Post-treatment	Placebo + DEC		245.6	Full Range 175 to 372	percent of baseline eosinophil count
Frequency of AE's	Reslizumab + DEC		29		adverse events
Frequency of AE's	Placebo + DEC		28		adverse events
Markers of Eosinophil Activation	Reslizumab + DEC	% day 0 EDN at day 7	115	Full Range 101 to 132	% change
Markers of Eosinophil Activation	Placebo + DEC	% day 0 EDN at day 7	377	Full Range 163 to 634	% change
Markers of Eosinophil Activation	Reslizumab + DEC	% day 0 EPO at day 7	138	Full Range 92 to 161	% change
Markers of Eosinophil Activation	Placebo + DEC	% day 0 EPO at day 7	203	Full Range 82 to 344	% change
Proportion of Subjects Who Clear Blood Microfilariae	Reslizumab	3 days	2		Participants
Proportion of Subjects Who Clear Blood Microfilariae	Placebo	3 days	2		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Reslizumab	4
Overall Study	STARTED	Placebo	4
Overall Study	COMPLETED	Reslizumab	4
Overall Study	COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Reslizumab	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fatigue	General disorders	Reslizumab + DEC	1	4
other	Fatigue	General disorders	Placebo + DEC	3	4
other	Nausea	Gastrointestinal disorders	Reslizumab + DEC	2	4
other	Nausea	Gastrointestinal disorders	Placebo + DEC	1	4
other	Headache	General disorders	Reslizumab + DEC	2	4
other	Headache	General disorders	Placebo + DEC	2	4
other	Calabar swelling	Skin and subcutaneous tissue disorders	Reslizumab + DEC	2	4
other	Calabar swelling	Skin and subcutaneous tissue disorders	Placebo + DEC	1	4
other	Pruritus	Skin and subcutaneous tissue disorders	Reslizumab + DEC	1	4
other	Pruritus	Skin and subcutaneous tissue disorders	Placebo + DEC	2	4

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Reslizumab + DEC	0	4
Total, all-cause mortality	Placebo + DEC	0	4
Total, other adverse events	Reslizumab + DEC	4	4
Total, other adverse events	Placebo + DEC	4	4
Total, serious adverse events	Reslizumab + DEC	0	4
Total, serious adverse events	Placebo + DEC	0	4

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
2037798	BACKGROUND	PubMed
2193099	BACKGROUND	PubMed
8158033	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Reslizumab + DEC vs Placebo + DEC: deaths from any cause	Trial comparisons
Reslizumab + DEC vs Placebo + DEC: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01111305

GET https://conductscience.org/api/trials/v1/NCT01111305/events?page=2

API reference For AI assistants