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INF904 for Chronic Urticaria and Hidradenitis Suppurativa
Fountain Valley, CA
Phase 2
Recruiting
Research Sponsored by InflaRx GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Subjects must be 18 years or older at the time of signing the informed consent.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial lasts for about 70 days, where participants will be screened for 14 days, receive treatment for 28 days, and then be observed for another 28 days. All participants will receive
See full description
Who is the study for?
This trial is for adults over 18 with moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa. Participants must sign informed consent and be able to follow the study schedule, which includes a screening, treatment period of 28 days, and a follow-up of another 28 days.Check my eligibility
What is being tested?
The trial tests different doses of INF904 on subjects with skin conditions like chronic urticaria and hidradenitis suppurativa. It includes low, medium, high dose treatments for HS; lower and higher dose treatments for CSU; plus a high dose for those who didn't respond to previous IgE therapies.See study design
What are the potential side effects?
While specific side effects are not listed here, common reactions may include irritation at the injection site, allergic reactions to the drug components, general discomfort or other symptoms related to immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Secondary study objectives
Maximum Plasma Concentration [Cmax]
Minimum Plasma Concentration [Cmin]
Systemic exposure, defined as the Area Under the Curve [AUC0-24]
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Arm 6 HDExperimental Treatment1 Intervention
High dose of IFN904 BID
Group II: Arm 5 HDExperimental Treatment1 Intervention
Medium dose of IFN904 BID
Group III: Arm 4 HSExperimental Treatment1 Intervention
Lower dose of IFN904 BID
Group IV: Arm 3 CSUExperimental Treatment1 Intervention
Non responders IgE, higher dose of IFN904 BID
Group V: Arm 2 CSUExperimental Treatment1 Intervention
Higher dose of IFN904 BID
Group VI: Arm 1 CSUExperimental Treatment1 Intervention
Lower dose of IFN904 BID
Find a Location
Closest Location:Forest Hills Dermatology Group· Kew Gardens, NY· 487 miles
Who is running the clinical trial?
InflaRx GmbHLead Sponsor
15 Previous Clinical Trials
2,220 Total Patients Enrolled