Use of CXCL9 as a Biomarker of Acthar Efficacy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02523092

Acronym

Acthar

Enrollment

Registered

2015-08-14

Start date

2022-11-03

Completion date

2026-12-31

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Keywords

sarcoidosis, Acthar, CXCL9, chemokine ligand 9

Brief summary

The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).

Detailed description

The investigators will test whether Acthar gel's anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar.

Interventions

DRUGActhar gel

Acthar gel given IM or SQ as per package insert

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement * Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate

Exclusion criteria

* Smoking * Cancer * Chronic infections (e.g. tuberculosis, viral, fungal, bacterial) * Inflammatory conditions * Coexisting lung disease * Congestive heart failure * Uncontrolled hypertension * Recent surgery * Active peptic ulcers * Osteoporosis

Design outcomes

Primary

Measure	Time frame
Decrease in blood CXCL9 levels by 50%	within 6 months

Secondary

Measure	Time frame
Improvement in FVC by 5% of predicted	within 6 months
Improvement in dyspnea score	within 6 months

Countries

United States

Contacts

Primary ContactLaura Koth, MD

Laura.Koth@ucsf.edu(415) 514-4369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026