Last reviewed · How we verify
NCT03656692
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Phase 4 trial testing Acthar Gel in Uveitis, Posterior in 5 participants. Terminated before completion.
14 July 2020
Quick facts
| Lead sponsor | Mallinckrodt |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 5 October 2018 |
| Primary completion | 14 July 2020 |
| Estimated completion | 14 July 2020 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Acthar Gel (CORTICOTROPIN) — full drug profile →
Conditions studied
- Uveitis, Posterior — all drugs for Uveitis, Posterior →
- Uveitis, Intermediate — all drugs for Uveitis, Intermediate →
- Panuveitis — all drugs for Panuveitis →
Sponsor
Mallinckrodt — full company profile →
Who can join
18 and older, any sex, with Uveitis, Posterior or Uveitis, Intermediate. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 44 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (6 terms — click to expand)
| Reaction | System | Acthar Gel |
|---|---|---|
| Uveitis | Eye disorders | — |
| Intraocular pressure increased | Investigations | — |
| Insomnia | Psychiatric disorders | — |
| Iris adhesions | Eye disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Drug hypersensitivity | Immune system disorders | — |
Data from ClinicalTrials.gov NCT03656692 adverse events section.
Sponsor's own description
The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea. Also, safety information when using it for this purpose will be collected.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03656692
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Acthar Gel
Trials testing the same drug.
- 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
- NCT02953821 — Acthar Gel for Active Systemic Lupus Erythematosus (SLE) · Phase 4 · completed
- 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 Uveitis, Posterior
Currently open trials in the same condition.
- NCT06431373 — A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis · Phase 3 · active not 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
- NCT03320070 — Acthar Gel in Participants With Pulmonary Sarcoidosis · Phase 4 · completed
- NCT03132428 — Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension · terminated
- NCT03068754 — Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS) · Phase 2, PHASE3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03656692 (US National Library of Medicine, public domain)
- 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: 3 August 2021
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/NCT03656692.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing