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Izokibep for Uveitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UveitisIzokibep - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing izokibep, a small protein molecule, as a possible treatment for active non-infectious uveitis, a condition which causes inflammation in the eye.

Eligible Conditions
  • Uveitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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CNS10-NPC implantation
1
Brepocitinib
1
1 mg ANXV - active

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week 10 up to Week 52

Baseline to Week 10
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Week 65
Incidence of clinically significant changes in laboratory values
Incidence of clinically significant changes in vital signs
Incidence of serious adverse events (SAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Week 10
Proportion of subjects that achieve quiescence
Week 52
Time to treatment failure defined as reaching treatment failure by meeting ≥ 1 of the 4 criteria specified in the protocol in at least 1 eye.
Week 24
Change in best corrected visual acuity (BCVA) from best state achieved
Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved
Week 52
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
CNS10-NPC implantation
2
Brepocitinib
2
1 mg ANXV - active

Trial Design

5 Treatment Groups

Group 2: Izokibep subcutaneous once weekly
1 of 5
Group 4: Izokibep subcutaneous every two weeks
1 of 5
Group 3: Izokibep subcutaneous once weekly
1 of 5
Group 2: Placebo subcutaneous every 2 weeks
1 of 5
Group 1: Placebo subcutaneous once weekly
1 of 5

Experimental Treatment

Non-Treatment Group

100 Total Participants · 5 Treatment Groups

Primary Treatment: Izokibep · Has Placebo Group · Phase 2

Group 2: Izokibep subcutaneous once weekly
Drug
Experimental Group · 1 Intervention: Izokibep · Intervention Types: Drug
Group 4: Izokibep subcutaneous every two weeks
Drug
Experimental Group · 1 Intervention: Izokibep · Intervention Types: Drug
Group 3: Izokibep subcutaneous once weekly
Drug
Experimental Group · 1 Intervention: Izokibep · Intervention Types: Drug
Group 2: Placebo subcutaneous every 2 weeks
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Group 1: Placebo subcutaneous once weekly
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 10 up to week 52

Who is running the clinical trial?

ACELYRIN Inc.Lead Sponsor
4 Previous Clinical Trials
616 Total Patients Enrolled
1 Trials studying Uveitis
7 Patients Enrolled for Uveitis
Paul M Peloso, MD, MSc.Study DirectorACELYRIN Inc.
1 Previous Clinical Trials
180 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have provided informed consent to comply with the requirements and restrictions listed in the ICF and in this protocol.
You are at least 18 years old.
You have non-infectious intermediate-, posterior- or pan-uveitis.
You have a uveitis of more than 2+ (in the SUN classification) or more than 1+ (in the NEI/SUN classification) by digital indirect ophthalmoscope and fundus photography.
You are currently receiving treatment with oral corticosteroids (≥ 7.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Clinical Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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