A Phase 2a double blind, randomized, parallel arm, placebo-controlled trial to investigate the effects of two dose levels of CIT-013 on disease activity in patients with Hidradenitis Suppurativa (HS)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521684-12-00

Acronym

CITRYLL003

Enrollment

Registered

2025-10-06

Start date

2026-01-13

Completion date

Unknown

Last updated

2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Brief summary

• Proportion of participants with HiSCR75 in pooled dose groups of CIT 013 (50 mg CIT-013 and 100 mg CIT-013) versus placebo at V11 (D85)

Detailed description

Incidence and severity of treatment-emergent (serious) adverse events ((S)AE)s, Change from baseline to Day 113 as measured by HiSCR50, HiSCR75 and HiSCR90 -, Change from baseline to Day 113 as measured by IHS4, Number of draining tunnels - change from baseline (V2) to all assessment timepoints (D29 [V5], D43 [V7], D85 [V11], D113 [V12]), Change in pain as reported by participant via numerical rating scale (NRS), Change in Quality of Life as assessed by participant by the DLQI, Change in Quality of Life as assessed by participant by the Hidradenitis Suppurativa Quality of Life (HiSQoL), Pharmacokinetic (PK) levels throughout the trial, per originally assigned treatment

Interventions

DRUGCIT-013

DRUGCommercially available sodium chloride 0.9% solution in water

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Proportion of participants with HiSCR75 in pooled dose groups of CIT 013 (50 mg CIT-013 and 100 mg CIT-013) versus placebo at V11 (D85)	—

Secondary

Measure	Time frame
Incidence and severity of treatment-emergent (serious) adverse events ((S)AE)s, Change from baseline to Day 113 as measured by HiSCR50, HiSCR75 and HiSCR90 -, Change from baseline to Day 113 as measured by IHS4, Number of draining tunnels - change from baseline (V2) to all assessment timepoints (D29 [V5], D43 [V7], D85 [V11], D113 [V12]), Change in pain as reported by participant via numerical rating scale (NRS), Change in Quality of Life as assessed by participant by the DLQI, Change in Quality of Life as assessed by participant by the Hidradenitis Suppurativa Quality of Life (HiSQoL), Pharmacokinetic (PK) levels throughout the trial, per originally assigned treatment	—

Measure

Time frame

—

Countries

Germany, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026