A Phase 4 interventional study of Acthar Gel and Placebo in Multiple Sclerosis, Relapsing-Remitting, sponsored by Mallinckrodt ARD LLC. Terminated at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by Mallinckrodt ARD LLC (part of Keenova Therapeutics plc) · Phase 4, Interventional, and Treatment
Among 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States — 26 open to participants now, 44 under way, 7 of them phase 3. Multiple Sclerosis, Relapsing-Remitting · United States.
Among the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States, this one is the 116th largest by enrollment of the 175 interventional ones, is one of 11 that started in 2017, is one of 20 in phase 4, and was the 132nd registered.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's enrollment of 35 is below the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →26 of the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States are open now, in 11 countries. Each count lists the studies.
Of the 59 Multiple Sclerosis, Relapsing-Remitting studies recruiting now, 11 (19%) set no upper age limit and 42 (71%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →229 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 11 started in 2017.
Median enrollment 64 across the 175 interventional studies, 49 across the 53 observational. Of the 164 that completed or were terminated, 81 (49%) have results posted.
114 of 229 have an industry lead sponsor. The 10 most frequent:
Mallinckrodt ARD LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Mallinckrodt ARD LLC has 1 study filed under Multiple Sclerosis, Relapsing-Remitting — fewer than ten, so there is no comparison to draw.
14 of the studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05201638Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT06700343Phase 3AmgenComparison Between ABP 692 and Ocrevus® (Ocrelizumab) | 2027-04-19 |
| NCT03958877Phase 3BiogenA Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | 2027-05-20 |
| NCT05327322University of Alabama at BirminghamFunctional Outcomes From Diets in Multiple Sclerosis | 2026-11-01 |
| NCT07355387University of Illinois at ChicagoHome Based Functional Balance Intervention for Multiple Sclerosis | 2026-11-24 |
Among the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States, from their registry updates:
This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).
Key Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
Drug: Acthar Gel
Participants receive Placebo under the skin once a day for 14 consecutive days
Drug: Placebo
Acthar Gel 1 mL (80U) for subcutaneous injection
Also known as: Repository Corticotropin Injection
Placebo for subcutaneous injection
Also known as: Matching Placebo
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.
Time frame: Baseline, Day 42
The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic.
| Milestone | Acthar Gel | Placebo |
|---|---|---|
| Started | 18 | 17 |
| Modified intent to treat (mitt) | 18 | 17 |
| Completed treatment | 17 | 17 |
| Completed | 18 | 17 |
| Not completed | 0 | 0 |
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.
| score on a scale | Acthar Gel | Placebo |
|---|---|---|
| Baseline | 3.86 ± 1.122 | 3.85 ± 1.169 |
| Day 42 | 2.92 ± 0.974 | 3.62 ± 1.485 |
Collected over 42 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acthar Gel | 0/18 (0%) | 0/18 (0%) | 14/18 (77.8%) |
| Placebo | 0/17 (0%) | 0/17 (0%) | 12/17 (70.6%) |
| Event | Acthar Gel | Placebo |
|---|---|---|
| Injection site bruisingGeneral disorders | 3/18 | 4/17 |
| Injection site erythemaGeneral disorders | 1/18 | 2/17 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/18 | 2/17 |
| HeadacheNervous system disorders | 0/18 | 2/17 |
| ContusionInjury, poisoning and procedural complications | 2/18 | 0/17 |
| InsomniaPsychiatric disorders | 2/18 | 0/17 |
| GoitreEndocrine disorders | 0/18 | 1/17 |
| Corneal degenerationEye disorders | 0/18 | 1/17 |
| Vision blurredEye disorders | 0/18 | 1/17 |
| DyspepsiaGastrointestinal disorders | 0/18 | 1/17 |
All participants
| Age, Continuous(years) | Acthar Gel | Placebo | Total |
|---|---|---|---|
| Median | 40 (21 to 62) | 43 (26 to 64) | 40 (21 to 64) |
| Age, Customized(Participants) | Acthar Gel | Placebo | Total |
|---|---|---|---|
| Adults 21-64 — ≤35 | 4 | 6 | 10 |
| Adults 21-64 — 36-45 | 10 | 6 | 16 |
| Adults 21-64 — 46-55 | 2 | 2 | 4 |
| Adults 21-64 — 56-64 | 2 | 3 | 5 |
| Sex: Female, Male(Participants) | Acthar Gel | Placebo | Total |
|---|---|---|---|
| Female | 15 | 12 | 27 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Acthar Gel | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 17 | 16 | 33 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Acthar Gel | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 15 | 15 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Acthar Gel | Placebo | Total |
|---|---|---|---|
| United States | 18 | 17 | 35 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
Ran from May 2017 to primary completion in Jul 2020, 37 months.
Results were first posted in Jun 2021, 10 months after primary completion.
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Studies of the drug tested here: Adrenocorticotropic Hormone
Multiple Sclerosis, Relapsing-Remitting →