Table of Contents
- Trial overview
- Who participates in these studies
- Conditions studied
- Phases and study designs
- Main outcomes and endpoints
- Trial-by-trial details
Trial overview
The trial data show that Hydrocortisone Sodium Phosphate is being studied in different clinical settings, not just one disease area.[2][3] In the available studies, it appears in research on acute lymphoblastic leukaemia, eye conditions, and inflammatory eye secretions.[2][3] The studies are designed to learn about benefit, safety, and how patients respond over time.[1][4]
Who participates in these studies
The target groups are different across trials.[1][2][3] One large protocol includes infants, children, and young adults with acute lymphoblastic leukaemia, with an enrollment of 8,503 participants.[2] Eye trials include adults with dry eye disease and moderate meibomian gland dysfunction, and patients with ocular prostheses who have inflammatory conjunctival secretions.[3][4] Another trial includes people with recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa.[1]
Conditions studied
The main condition in the largest study is acute lymphoblastic leukaemia, a cancer of the blood and bone marrow.[2] In the eye studies, the conditions are dry eye disease with moderate meibomian gland dysfunction and inflammatory secretions of the conjunctiva in patients with ocular prostheses.[3][4] The data also include trials in recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, which are serious skin conditions.[1]
Phases and study designs
The studies include Phase 3, Phase 4, and one low-intervention trial.[1][2][3][4] Phase 3 trials often compare treatments in larger groups to see how well they work and how safe they are.[1][4] Phase 4 research usually happens later and can help learn more about treatment results in broader use.[2] The low-intervention study uses a simpler comparison design in a small group of 30 participants.[3]
Some studies compare Hydrocortisone Sodium Phosphate with other treatments or with a control group.[2][3] For example, one eye study compares topical hydrocortisone with dexamethasone and a tear substitute.[3] The leukemia protocol includes several treatment paths and compares outcomes with control populations or historical controls.[2]
Main outcomes and endpoints
The trials measure different endpoints, depending on the disease being studied.[1][2][3][4] In the leukemia protocol, the main outcomes include event-free survival, disease-free survival, and the fraction of patients with undetectable MRD after one cycle of blinatumomab in a specific subgroup.[2] These are important because they show whether treatment helps patients stay free from relapse or other bad events.[2]
In the eye studies, researchers measure symptom scores, inflammatory markers in tears, and eye safety outcomes such as intraocular pressure.[3][4] One trial uses the Secretion Self-Rating Scale score to track how patients rate their conjunctival secretions.[3] Another trial looks at change in dry eye and meibomian gland dysfunction symptom scores from day 0 to day 14, as well as changes in tear cytokines and eye pressure over time.[4]
In the epidermolysis bullosa study, the main endpoint is the proportion of subjects with complete target wound closure at Month 6, confirmed 2 weeks later.[1] This endpoint checks whether the wound is fully closed and stays closed for a short follow-up period.[1]
Trial-by-trial details
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NCT04307576 is a large Phase 4 protocol for participants 0-45 years old with acute lymphoblastic leukaemia.[2] It is authorised and has an enrollment of 8,503 participants.[2] Hydrocortisone Sodium Phosphate is given intrathecally, which means into the spinal fluid space.[2]
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NCT05668455 is a low-intervention study in adults with inflammatory secretions of the conjunctiva and ocular prostheses.[3] It compares topical hydrocortisone with dexamethasone and a tear substitute, and measures a secretion rating score.[3] The study is authorised and includes 30 participants.[3]
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2024-518093-13-00 is a completed Phase 3 study in dry eye disease with moderate meibomian gland dysfunction.[4] It includes 54 participants and measures symptom change, tear cytokines, and increased intraocular pressure.[4] The trial uses topical Softacort as the Hydrocortisone Sodium Phosphate-related treatment in the eye.[4]
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NCT05464381 is a Phase 3 authorised trial in recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa.[1] It includes 167 participants and studies intravenous allo-APZ2-OTS versus placebo, with an additional open-label arm for some patients.[1] The main outcome is complete target wound closure at Month 6.[1]
