Trial Outcomes & Findings for Use of CXCL9 as a Biomarker of Acthar Efficacy (NCT NCT02523092)
NCT ID: NCT02523092
Last Updated: 2026-04-30
Results Overview
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.
TERMINATED
PHASE4
2 participants
within 6 months
2026-04-30
Participant Flow
Participant milestones
| Measure |
Acthar Gel
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.
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of CXCL9 as a Biomarker of Acthar Efficacy
Baseline characteristics by cohort
| Measure |
Acthar Gel
n=2 Participants
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.
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|---|---|
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Sex: Female, Male
Female
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1 Participants
n=14 Participants
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Sex: Female, Male
Male
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1 Participants
n=14 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=14 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=14 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=14 Participants
|
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Race (NIH/OMB)
Black or African American
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1 Participants
n=14 Participants
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Race (NIH/OMB)
White
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1 Participants
n=14 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=14 Participants
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Region of Enrollment
United States
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2 Participants
n=14 Participants
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Age, Categorical
<=18 years
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0 Participants
n=14 Participants
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Age, Categorical
Between 18 and 65 years
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2 Participants
n=14 Participants
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Age, Categorical
>=65 years
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0 Participants
n=14 Participants
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PRIMARY outcome
Timeframe: within 6 monthsPopulation: for the two participants, blood samples were analyzed before starting Acthar gel and at the last visit time point at 6 months. Therefore, two time points were analyzed per participant.
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.
Outcome measures
| Measure |
Observational Arm
n=2 Participants
observational arm
|
|---|---|
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Number of Participants That Show a Decrease in Blood CXCL9 Levels by 50%
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0 Participants
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SECONDARY outcome
Timeframe: within six monthsOutcome measures
| Measure |
Observational Arm
n=2 Participants
observational arm
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|---|---|
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Participants With Improvement in Forced Vital Capacity (FVC) Liters by 5 Percent or More
Yes
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1 Participants
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Participants With Improvement in Forced Vital Capacity (FVC) Liters by 5 Percent or More
No
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1 Participants
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SECONDARY outcome
Timeframe: within 6 monthsThe University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) is a 24-item patient-reported outcome measure that assesses the severity of dyspnea during activities of daily living. Participants rate shortness of breath for each activity on a 6-point scale from 0 ("not at all") to 5 ("maximally or unable to do because of breathlessness"). Item scores are summed to generate a total score ranging from 0 to 120. Higher total scores represent worse dyspnea severity, while lower scores indicate less dyspnea. The SOBQ does not contain separate subscales; all 24 items are equally weighted and combined by simple summation to calculate the total score. If a participant does not routinely perform an activity, they are instructed to estimate anticipated dyspnea, minimizing missing data.
Outcome measures
| Measure |
Observational Arm
n=2 Participants
observational arm
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|---|---|
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Participants With Improvement in Dyspnea Score
Yes
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1 Participants
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Participants With Improvement in Dyspnea Score
No
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1 Participants
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Adverse Events
Acthar Gel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place