NCT02523092

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
7.2 years until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 30, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

August 10, 2015

Results QC Date

January 6, 2026

Last Update Submit

April 13, 2026

Conditions

Sarcoidosis

Keywords

sarcoidosisActharCXCL9chemokine ligand 9

Outcome Measures

Primary Outcomes (1)

  • Number of Participants That Show a Decrease in Blood CXCL9 Levels by 50%

    Quantitative polymerase chain reaction assay was used to measure the gene expression for the gene CXCL9 using whole blood samples. The change in cycle threshold from before starting medication to the end of treatment was calculated. From this calculation, the number of participants that met the criteria of a 50% or greater drop in CXCL9 levels is reported.

    within 6 months

Secondary Outcomes (2)

  • Participants With Improvement in Forced Vital Capacity (FVC) Liters by 5 Percent or More

    within six months

  • Participants With Improvement in Dyspnea Score

    within 6 months

Study Arms (1)

Acthar gel

EXPERIMENTAL

After a 4-week period of baseline monitoring, Acthar gel will be administered by intramuscular or subcutaneous injection. Initial dosing will be 40 U every 72 hours (or twice per week) for 4 weeks. Dosage will then be increased to 80 U with similar frequency for 8 weeks and up to 16 weeks.

Drug: Acthar gel

Interventions

Acthar gelDRUG

Acthar gel given IM or SQ as per package insert

Also known as: Acthar
Acthar gel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Su R, Li MM, Bhakta NR, Solberg OD, Darnell EP, Ramstein J, Garudadri S, Ho M, Woodruff PG, Koth LL. Longitudinal analysis of sarcoidosis blood transcriptomic signatures and disease outcomes. Eur Respir J. 2014 Oct;44(4):985-93. doi: 10.1183/09031936.00039714. Epub 2014 Aug 19.

    PMID: 25142485BACKGROUND

Related Links

MeSH Terms

Conditions

Sarcoidosis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Limitations and Caveats

Study was terminated by sponsor.

Results Point of Contact

Title
Laura Koth, MD
Organization
UCSF
sarcoidosis@ucsf.edu
415-476-9225

Study Officials

  • Laura Koth, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 14, 2015

Study Start

November 3, 2022

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

April 30, 2026

Results First Posted

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)