NCT06555328 is a Phase 2 clinical trial of CSU lower dose treatment in Chronic Urticaria, Idiopathic, sponsored by InflaRx GmbH.

Who is sponsoring NCT06555328?

NCT06555328 is sponsored by InflaRx GmbH.

What drugs are being tested in NCT06555328?

Interventions in NCT06555328: CSU lower dose treatment, CSU high dose treatment, CSU non responders IgE - high dose treatment, HS low dose treatment, HS medium dose treatment, HS high dose treatment.

What condition does NCT06555328 study?

NCT06555328 studies Chronic Urticaria, Idiopathic, Hidradenitis, Hidradenitis Suppurativa.

Is NCT06555328 still recruiting?

NCT06555328 is currently terminated. Last updated 3 February 2026.

Last reviewed 2026-02-03 · How we verify

NCT06555328

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

Terminated Phase 2 Last updated 3 February 2026

What this trial tests

Phase 2 trial testing CSU lower dose treatment in Chronic Urticaria, Idiopathic in 73 participants. Terminated before completion.

Timeline

2 January 2025

Primary endpoint
22 January 2026

22 January 2026

Quick facts

Lead sponsor	InflaRx GmbH
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	2 January 2025
Primary completion	22 January 2026
Estimated completion	22 January 2026
Sites	29 locations across Georgia, Greece, Germany, Poland, Bulgaria, United States

Drugs / interventions tested

CSU lower dose treatment — full drug profile →
CSU high dose treatment — full drug profile →
CSU non responders IgE - high dose treatment
HS low dose treatment — full drug profile →
HS medium dose treatment — full drug profile →
HS high dose treatment — full drug profile →

Conditions studied

Chronic Urticaria, Idiopathic — all drugs for Chronic Urticaria, Idiopathic →
Hidradenitis — all drugs for Hidradenitis →
Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

InflaRx GmbH — full company profile →

Who can join

Adults 18 to 99, any sex, with Chronic Urticaria, Idiopathic or Hidradenitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Update on the Treatment of Chronic Spontaneous Urticaria.
Kolkhir P, Fok JS, Kocatürk E, Li PH, et al · · 2025 · cited 10× · PMID 40074986 · DOI 10.1007/s40265-025-02170-4
Emerging IgE and non-IgE targeted therapies for chronic urticaria.
Chhiba KD, Saini SS. · · 2026 · cited 1× · PMID 41270830 · DOI 10.1016/j.anai.2025.11.008

Verify or expand the search:

Other recruiting trials for Chronic Urticaria, Idiopathic

Currently open trials in the same condition.

NCT05916937 — Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria · Phase 4 · recruiting

Other InflaRx GmbH trials

Trials by the same sponsor.

NCT05964413 — Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum · Phase 3 · terminated
NCT04812535 — Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. · Phase 2 · terminated
NCT04333420 — Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia · Phase 2, PHASE3 · completed
NCT03971643 — Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum · Phase 2 · completed
NCT03895801 — Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06555328 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by InflaRx GmbH
Last refreshed: 3 February 2026

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/NCT06555328.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing