Trial Outcomes & Findings for Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes (NCT NCT02134717)

Results Overview

General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-12-03

Participant Flow

Subjects with sarcoidosis stage II and active disease

Willing to undergo two Bronchoalveolar lavages

Participant milestones

Participant milestones
Measure	Sarcoidosis Stage II All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration. all subjects will receive maraviroc 300mg orally twice a day for 6 weeks Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins. venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories. Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This study was terminated due to inadequate funding to complete the recruitment and analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sarcoidosis Stage II n=3 Participants All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration. all subjects will receive maraviroc 300mg orally twice a day for 6 weeks Bronchoscopy with bronchoalveolar lavage: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins. venipunctures: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories. Skin biopsy: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.
Age, Categorical <=18 years	0 Participants n=3 Participants • This study was terminated due to inadequate funding to complete the recruitment and analysis.
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants • This study was terminated due to inadequate funding to complete the recruitment and analysis.
Age, Categorical >=65 years	0 Participants n=3 Participants • This study was terminated due to inadequate funding to complete the recruitment and analysis.
Age, Continuous	37 years n=3 Participants • This study was terminated due to inadequate funding to complete the recruitment and analysis.
Sex: Female, Male Female	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=3 Participants
Region of Enrollment United States	3 participants n=3 Participants • This study was terminated due to inadequate funding to complete the recruitment and analysis.

PRIMARY outcome

Timeframe: 6 weeks

Population: Data could not be analyzed

General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study was terminated before data were collected for this outcome measure.

MNC activation and T-cell differentiation before and after CCR5 inhibition.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Study was terminated before data were collected for this outcome measure.

CCR5 expression among these immune effector cells before and after CCR5 inhibition.

Outcome measures

Outcome data not reported

Adverse Events

Sarcoidosis Stage II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin Gibson MD

University of Pittsburgh

Phone: 412-624-7095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place