Use of CXCL9 as a Biomarker of Acthar Efficacy (Acthar)
Sponsor: Mallinckrodt
Terminated
sponsor closed study down
Listed as NCT02523092, this observational or N/A phase trial focuses on Sarcoidosis and remains terminated or withdrawn. Sponsored by Mallinckrodt, it has been updated 12 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
12 versions recorded-
May 4, 2026 — Present [daily]
Terminated
Status: Recruiting → Terminated · Phase: PHASE4 → None
-
Sep 2024 — May 2026 [monthly]
Recruiting PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE4
-
Jun 2023 — Jul 2024 [monthly]
Recruiting PHASE4
Status: Not Yet Recruiting → Recruiting
-
Jan 2021 — Jun 2023 [monthly]
Not Yet Recruiting PHASE4
▶ Show 7 earlier versions
-
Apr 2020 — Jan 2021 [monthly]
Not Yet Recruiting PHASE4
-
Aug 2019 — Apr 2020 [monthly]
Not Yet Recruiting PHASE4
-
Dec 2018 — Aug 2019 [monthly]
Not Yet Recruiting PHASE4
Status: Unknown Status → Not Yet Recruiting
-
Nov 2018 — Dec 2018 [monthly]
Unknown Status PHASE4
Status: Not Yet Recruiting → Unknown Status
-
Jun 2018 — Nov 2018 [monthly]
Not Yet Recruiting PHASE4
-
Feb 2017 — Jun 2018 [monthly]
Not Yet Recruiting PHASE4
-
Jan 2017 — Feb 2017 [monthly]
Not Yet Recruiting PHASE4
First recorded
Eligibility 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).
Contact Information
- Mallinckrodt
- University of California, San Francisco
For direct contact, visit the study record on ClinicalTrials.gov .