A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab (ABT-981) in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa

Conditions

Hidradenitis Suppurativa

Brief summary

The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.

Detailed description

Ranked Secondary Endpoints: Achievement of NRS30 (at least a 30% reduction and at least 2-units reduction from Baseline in the Patient's Global Assessment of HS-related skin pain NRS) at Week 8 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain); ", Change from Baseline in DLQI at Week 16 among subjects ≥ 16 years of age at Baseline;, Change from Baseline in HSIA at Week 16, Change from Baseline in HSSA Worst Drainage Score at Week 16;, Change from Baseline in Draining Fistula at Week 16 among subjects with at least 1 draining fistula at Baseline;, Achievement of HiSCR 90 (at least a 90% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline) at Week 16;, Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) at Week 8;, Change from Baseline in HSSA at Week 16;, Change from Baseline in HS-related odor (smell), based on HSSA Question 8, at Week 16;, Occurrence of HS flare, defined as at least one occurrence of a ≥ 25% increase in AN count with a minimum absolute increase of 2 relative to Baseline during the first 16 weeks (Period 1)., Change from Baseline in HSIA Emotional Domain at Week 16;, Change from Baseline in HSIA Mobility Domain at Week 16.

Related papers

No related papers found yet.

Interventions

DRUGLutikizumab

DRUGPlacebo of Lutikizumab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.	—

Secondary

Measure	Time frame
Ranked Secondary Endpoints: Achievement of NRS30 (at least a 30% reduction and at least 2-units reduction from Baseline in the Patient's Global Assessment of HS-related skin pain NRS) at Week 8 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain); ", Change from Baseline in DLQI at Week 16 among subjects ≥ 16 years of age at Baseline;, Change from Baseline in HSIA at Week 16, Change from Baseline in HSSA Worst Drainage Score at Week 16;, Change from Baseline in Draining Fistula at Week 16 among subjects with at least 1 draining fistula at Baseline;, Achievement of HiSCR 90 (at least a 90% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline) at Week 16;, Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) at Week 8;, Change from Baseline in HSSA at Week 16;, Change from Baseline in HS-related odor (smell)	—

Measure

Time frame

Ranked Secondary Endpoints: Achievement of NRS30 (at least a 30% reduction and at least 2-units reduction from Baseline in the Patient's Global Assessment of HS-related skin pain NRS) at Week 8 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain); ", Change from Baseline in DLQI at Week 16 among subjects ≥ 16 years of age at Baseline;, Change from Baseline in HSIA at Week 16, Change from Baseline in HSSA Worst Drainage Score at Week 16;, Change from Baseline in Draining Fistula at Week 16 among subjects with at least 1 draining fistula at Baseline;, Achievement of HiSCR 90 (at least a 90% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline) at Week 16;, Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) at Week 8;, Change from Baseline in HSSA at Week 16;, Change from Baseline in HS-related odor (smell)

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Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed