Phase 2, randomized, double-blind, placebo-controlled study of IC0624 as first-line therapy in patients with active mild to moderate Hidradenitis Suppurativa (HS)

Conditions

Hidradenitis Suppurativa

Brief summary

The primary endpoint will be the HiSCR50 at week 6.

Detailed description

Secondary efficacy endpoints: HiSCR50 at weeks 2 and 4; HiSCR75 at weeks 2, 4 and 6; AN (Abscesses and Inflammatory Nodules) count at weeks 2, 4 and 6; IHS4 at weeks 2, 4 and 6; Inflammation marker hsCRP at week 6 in comparison with baseline measurement at week 0, Secondary pain endpoint: Maximum daily pain sensation based on diary documentation within preceding 24 hours; Intake of pain medication for HS, Secondary safety and tolerability endpoints: (Serious) Adverse Events; Laboratory analysis at week 6 in comparison with analysis at week 0 (baseline) for liver transaminases (GGT, GOT/AST, GPT/ALT), creatinine, CK, HDL and LDL cholesterol, differential blood count., Secondary QoL endpoints: DLQI at week 6 in comparison with week 0 (past 7 days assessment); WHO-5 at week 6 in comparison with baseline at week 0; Indication of subjective satisfaction with the study treatment based on verbally asked questions at week 6

Related papers

No related papers found yet.

Interventions

DRUGICHTHRALETTEN® 200 mg magensaftresistente Tabletten Wirkstoff: Natriumbituminosulfonat

DRUGTrockensubstanz

DRUGIchthraletten - Placebo

DRUGGastro Resistant Tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the HiSCR50 at week 6.	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: HiSCR50 at weeks 2 and 4; HiSCR75 at weeks 2, 4 and 6; AN (Abscesses and Inflammatory Nodules) count at weeks 2, 4 and 6; IHS4 at weeks 2, 4 and 6; Inflammation marker hsCRP at week 6 in comparison with baseline measurement at week 0, Secondary pain endpoint: Maximum daily pain sensation based on diary documentation within preceding 24 hours; Intake of pain medication for HS, Secondary safety and tolerability endpoints: (Serious) Adverse Events; Laboratory analysis at week 6 in comparison with analysis at week 0 (baseline) for liver transaminases (GGT, GOT/AST, GPT/ALT), creatinine, CK, HDL and LDL cholesterol, differential blood count., Secondary QoL endpoints: DLQI at week 6 in comparison with week 0 (past 7 days assessment); WHO-5 at week 6 in comparison with baseline at week 0; Indication of subjective satisfaction with the study treatment based on verbally asked questions at week 6	—

Measure

Time frame

Secondary efficacy endpoints: HiSCR50 at weeks 2 and 4; HiSCR75 at weeks 2, 4 and 6; AN (Abscesses and Inflammatory Nodules) count at weeks 2, 4 and 6; IHS4 at weeks 2, 4 and 6; Inflammation marker hsCRP at week 6 in comparison with baseline measurement at week 0, Secondary pain endpoint: Maximum daily pain sensation based on diary documentation within preceding 24 hours; Intake of pain medication for HS, Secondary safety and tolerability endpoints: (Serious) Adverse Events; Laboratory analysis at week 6 in comparison with analysis at week 0 (baseline) for liver transaminases (GGT, GOT/AST, GPT/ALT), creatinine, CK, HDL and LDL cholesterol, differential blood count., Secondary QoL endpoints: DLQI at week 6 in comparison with week 0 (past 7 days assessment); WHO-5 at week 6 in comparison with baseline at week 0; Indication of subjective satisfaction with the study treatment based on verbally asked questions at week 6

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Countries

Germany

Outcome results

None listed