A Phase 4 interventional study of Acthar Gel and Placebo Gel in Lupus Erythematosus, Systemic, sponsored by Mallinckrodt. Completed at 39 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Mallinckrodt · Phase 4, Interventional, and Treatment
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE).
The doctor will assign eligible patients to one of two groups (like flipping a coin).
Participants will receive the treatment assigned to their group for 24 weeks:
The doctor or his staff will take measurements and ask questions to:
This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 172 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Mallinckrodt is the lead sponsor of 84 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this trial, a patient must:
Have a documented history or screening result of
Have been on prednisone (or prednisone equivalent) before the screening visit:
Exclusion criteria:
A patient is not eligible to participate if he/she:
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Drug: Acthar Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Drug: Placebo Gel
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Also known as: Repository corticotropin
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Also known as: Matching placebo
Physician's Global Assessment (PGA)
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Time frame: Baseline, Week 16, Week 24
British Isles Lupus Assessment Group 2004 (BILAG 2004)
BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
Time frame: Baseline, Week 16, Week 24
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.
Time frame: Week 16, Week 24
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
Among some adults, having a period of SLE symptoms-called flares-may happen every so often, sometimes even years apart, and go away at other times-called remission. The SFI categorizes SLE flares as mild, moderate or severe.
Time frame: Week 16
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
The CLASI total activity score reflects ongoing inflammation that can be treated, with points given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Mild, moderate, and severe disease correspond with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity, lower scores indicate improvement.
Time frame: at Baseline and Weeks 4, 8, and 16
Mean Number of Swollen or Tender Joints on the 28-Joint Count
The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
Time frame: at Baseline and at Weeks 4, 8, 12 and 16
Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24
Time frame: Week 20, Week 24
| Milestone | Placebo Gel | Acthar Gel |
|---|---|---|
| Started | 86 | 86 |
| Safety population | 86 | 86 |
| Modified intent to treat (mitt) populati | 85 | 84 |
| Per protocol (pp) population | 72 | 75 |
| Completed week 16 visit | 76 | 77 |
| Completed study treatment (week 24) | 73 | 76 |
| Completed | 71 | 73 |
| Not completed | 15 | 13 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Progressive disease | 5 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Change of address | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Out of state for indeterminate time | 0 | 1 |
| Withdrew: No improvement | 0 | 1 |
| Withdrew: Refused follow-up visit | 2 | 1 |
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
| score on a scale | Placebo Gel | Acthar Gel |
|---|---|---|
| Baseline | 58.8 ± 15.81 | 60.6 ± 16.69 |
| Week 16 | 33.2 ± 18.77 | 30.2 ± 14.89 |
| Week 24 | 26.9 ± 17.76 | 25.5 ± 17.22 |
BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
| score on a scale | Placebo Gel | Acthar Gel |
|---|---|---|
| Baseline | 18.2 ± 5.15 | 18.0 ± 5.45 |
| Week 16 | 9.7 ± 6.57 | 7.7 ± 5.91 |
| Week 24 | 8.0 ± 6.21 | 6.9 ± 5.87 |
The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.
| Participants | Placebo Gel | Acthar Gel |
|---|---|---|
| Week 16 | 40 | 41 |
| Week 24 | 46 | 44 |
Among some adults, having a period of SLE symptoms-called flares-may happen every so often, sometimes even years apart, and go away at other times-called remission. The SFI categorizes SLE flares as mild, moderate or severe.
| Participants | Placebo Gel | Acthar Gel |
|---|---|---|
| Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 | 3 | 0 |
The CLASI total activity score reflects ongoing inflammation that can be treated, with points given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Mild, moderate, and severe disease correspond with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity, lower scores indicate improvement.
| score on a scale | Placebo Gel | Acthar Gel |
|---|---|---|
| Baseline | 7.1 ± 6.53 | 7.9 ± 7.48 |
| Week 4 | 5.8 ± 5.57 | 5.6 ± 5.30 |
| Week 8 | 5.0 ± 5.19 | 5.0 ± 5.41 |
| Week 12 | 4.5 ± 5.41 | 4.0 ± 4.08 |
| Week 16 | 3.8 ± 4.36 | 3.4 ± 3.77 |
The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
| Joints | Placebo Gel | Acthar Gel |
|---|---|---|
| Baseline | 7.2 ± 4.98 | 8.2 ± 5.85 |
| Week 4 | 4.9 ± 4.77 | 4.2 ± 4.24 |
| Week 8 | 3.8 ± 4.97 | 2.9 ± 3.42 |
| Week 12 | 2.9 ± 4.40 | 2.3 ± 3.00 |
| Week 16 | 2.8 ± 3.67 | 1.9 ± 3.20 |
| Participants | Placebo Gel | Acthar Gel |
|---|---|---|
| Week 20 | 5 | 3 |
| Week 24 | 6 | 4 |
Collected over 24 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Gel | 1/86 (1.2%) | 8/86 (9.3%) | 23/86 (26.7%) |
| Acthar Gel | 0/86 (0%) | 4/86 (4.7%) | 31/86 (36%) |
| Event | Placebo Gel | Acthar Gel |
|---|---|---|
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 1/86 | 2/86 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/86 | 0/86 |
| AppendicitisInfections and infestations | 1/86 | 0/86 |
| GastroenteritisInfections and infestations | 1/86 | 0/86 |
| Herpes zosterInfections and infestations | 0/86 | 1/86 |
| PeritonitisInfections and infestations | 1/86 | 0/86 |
| PneumoniaInfections and infestations | 1/86 | 0/86 |
| PyelonephritisInfections and infestations | 1/86 | 0/86 |
| Soft tissue infectionInfections and infestations | 1/86 | 0/86 |
| Drug abusePsychiatric disorders | 1/86 | 0/86 |
| Event | Placebo Gel | Acthar Gel |
|---|---|---|
| Urinary tract infectionInfections and infestations | 10/86 | 6/86 |
| Upper respiratory tract infectionInfections and infestations | 1/86 | 9/86 |
| InsomniaPsychiatric disorders | 4/86 | 7/86 |
| NasopharyngitisInfections and infestations | 6/86 | 3/86 |
| HeadacheNervous system disorders | 5/86 | 6/86 |
| HypertensionVascular disorders | 0/86 | 6/86 |
Safety Population (except for study-specific measures)
| Age, Continuous(years) | Placebo Gel | Acthar Gel | Total |
|---|---|---|---|
| Mean | 39.3 ± 12.99 | 40.1 ± 12.45 | 39.7 ± 12.69 |
| Sex: Female, Male(Participants) | Placebo Gel | Acthar Gel | Total |
|---|---|---|---|
| Female | 82 | 76 | 158 |
| Male | 4 | 10 | 14 |
| Race (NIH/OMB)(Participants) | Placebo Gel | Acthar Gel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 19 | 19 | 38 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 9 | 17 |
| White | 30 | 33 | 63 |
| More than one race | 29 | 25 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: No
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Lupus Erythematosus, Systemic→
Mallinckrodt