18 and older, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Physician's Global Assessment (PGA)Primary· Baseline, Week 16, Week 24
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Baseline
Group
Value
95% CI
Placebo Gel
58.8
± 15.81
Acthar Gel
60.6
± 16.69
Week 16
Group
Value
95% CI
Placebo Gel
33.2
± 18.77
Acthar Gel
30.2
± 14.89
Week 24
Group
Value
95% CI
Placebo Gel
26.9
± 17.76
Acthar Gel
25.5
± 17.22
British Isles Lupus Assessment Group 2004 (BILAG 2004)Primary· Baseline, Week 16, Week 24
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 syste
Baseline
Group
Value
95% CI
Placebo Gel
18.2
± 5.15
Acthar Gel
18.0
± 5.45
Week 16
Group
Value
95% CI
Placebo Gel
9.7
± 6.57
Acthar Gel
7.7
± 5.91
Week 24
Group
Value
95% CI
Placebo Gel
8.0
± 6.21
Acthar Gel
6.9
± 5.87
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)Primary· Week 16, Week 24
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.
Week 16
Group
Value
95% CI
Placebo Gel
40
Acthar Gel
41
Week 24
Group
Value
95% CI
Placebo Gel
46
Acthar Gel
44
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16Secondary· 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.
Group
Value
95% CI
Placebo Gel
3
Acthar Gel
0
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity ScoreSecondary· at Baseline and Weeks 4, 8, and 16
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.
Baseline
Group
Value
95% CI
Placebo Gel
7.1
± 6.53
Acthar Gel
7.9
± 7.48
Week 4
Group
Value
95% CI
Placebo Gel
5.8
± 5.57
Acthar Gel
5.6
± 5.30
Week 8
Group
Value
95% CI
Placebo Gel
5.0
± 5.19
Acthar Gel
5.0
± 5.41
Week 12
Group
Value
95% CI
Placebo Gel
4.5
± 5.41
Acthar Gel
4.0
± 4.08
Week 16
Group
Value
95% CI
Placebo Gel
3.8
± 4.36
Acthar Gel
3.4
± 3.77
Mean Number of Swollen or Tender Joints on the 28-Joint CountSecondary· at Baseline and at Weeks 4, 8, 12 and 16
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.
Baseline
Group
Value
95% CI
Placebo Gel
7.2
± 4.98
Acthar Gel
8.2
± 5.85
Week 4
Group
Value
95% CI
Placebo Gel
4.9
± 4.77
Acthar Gel
4.2
± 4.24
Week 8
Group
Value
95% CI
Placebo Gel
3.8
± 4.97
Acthar Gel
2.9
± 3.42
Week 12
Group
Value
95% CI
Placebo Gel
2.9
± 4.40
Acthar Gel
2.3
± 3.00
Week 16
Group
Value
95% CI
Placebo Gel
2.8
± 3.67
Acthar Gel
1.9
± 3.20
Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24Secondary· Week 20, Week 24
Week 20
Group
Value
95% CI
Placebo Gel
5
Acthar Gel
3
Week 24
Group
Value
95% CI
Placebo Gel
6
Acthar Gel
4
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 Weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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:
* Acthar Gel
* Placebo Gel, which looks like Acthar Gel, but has no medicine in it.
The doctor or his staff will take measurements and ask questions to:
* see how well the gel is working
* see how safe it is for patients with SLE
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03656692 — Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
· Phase 4
· terminated
NCT03320070 — Acthar Gel in Participants With Pulmonary Sarcoidosis
· Phase 4
· completed
NCT03126760 — Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
· Phase 4
· terminated
NCT02919761 — Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
· Phase 4
· completed
NCT02633046 — Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
· Phase 4
· completed
Other recruiting trials for Lupus Erythematosus, Systemic
Currently open trials in the same condition.
NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
· recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
· Phase 3
· recruiting
NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
· recruiting
NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I
· Phase 2
· recruiting
NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus
· Phase 1
· recruiting
Other Mallinckrodt trials
Trials by the same sponsor.
NCT04169061 — Impact of Acthar on Everyday Life of Participants With Severe Keratitis
· Phase 4
· completed
NCT03712280 — MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
· Phase 2
· completed
NCT03656692 — Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
· Phase 4
· terminated
NCT03320070 — Acthar Gel in Participants With Pulmonary Sarcoidosis
· Phase 4
· completed
NCT03132428 — Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mallinckrodt
Last refreshed: 20 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02953821.