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NCT05233397 · ClinicalTrials.gov registry record · Phase 2
ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
A Phase 2 study of Adamantinomatous Craniopharyngioma and Recurrent Adamantinomatous Craniopharyngioma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 12
- Study locations
NCT05233397: Recruiting Phase 2 study of Adamantinomatous Craniopharyngioma and Recurrent Adamantinomatous Craniopharyngioma, sponsored by Nationwide Children's Hospital.
NCT05233397 is a Phase 2 study of Adamantinomatous Craniopharyngioma and Recurrent Adamantinomatous Craniopharyngioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05233397, a Phase 2 study of Adamantinomatous Craniopharyngioma and Recurrent Adamantinomatous Craniopharyngioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 12
- Study locations
Study Summary
ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.
Primary Outcome
To calculate the number of patients who experience sustained objective response rate \[minor response (MR) + partial response (PR) + complete response (CR)\] of patients with recurrent/progressive previously irradiated Adamantinomatous Craniopharyngioma to treatment with systemic tocilizumab (Stratum 1).
Conditions Studied
Interventions
- DRUG Tocilizumab
Study Locations (12)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Nicklaus Children's Hospital - Miami
North Carolina
- Duke Children's Hospital - Durham
Texas
- Texas Children's Hospital - Houston
Washington
- Seattle Children's Hospital - Seattle
New South Wales
- Sydney Children's Hospital - Randwick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What NCT05233397 shows while recruiting
NCT05233397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Adamantinomatous Craniopharyngioma appearing as the primary indexed condition, and to 1 intervention - of which Tocilizumab is the first listed.
NCT05233397 lists 12 locations in 11 states (Ohio, Colorado, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05233397 about?
NCT05233397 is a clinical study titled "ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma". ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous C...
What is the current status of trial NCT05233397?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2022-12-16. Estimated completion is 2029-12.
What conditions does trial NCT05233397 study?
This clinical trial studies the following conditions: Adamantinomatous Craniopharyngioma, Recurrent Adamantinomatous Craniopharyngioma.
What interventions are being tested in trial NCT05233397?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT05233397?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05233397 being conducted?
This trial has 12 study locations across Colorado, District of Columbia, Florida, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05233397's enrollment target sits among peer trials
38 1467th of 2000 higher than 518 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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