GALLOP

17 evidence topics · 6 sources

Objective

Imsidolimab in participants with GPP

“efficacy and safety” (opens the source at this quote in a new tab)

Location and study date

Geographic scope reported by the sponsor

“United States and Europe” (opens the source at this quote in a new tab)

Study design

Phase 2 study design

“open-label, single-arm, multiple-dose study” (opens the source at this quote in a new tab)

Eligibility criteria

Disease activity thresholds described in the sponsor report

Inclusion criterion	Minimum value
Modified Japanese Dermatology Association severity index	“7”
Body surface area with active pustules and erythema	“10%”

Treatment

GALLOP: dosing

“750mg IV dose of imsidolimab” (opens the source at this quote in a new tab)
“monthly 100mg subcutaneous dose of imsidolimab beginning at Week 4 and continued through Week 12.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using CGI response as the primary endpoint

Primary endpoint and assessment times

“clinical response at weeks 4 and 16” (opens the source at this quote in a new tab)

Independent validation of the primary response definition

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

Population	Approximate planned participants
GALLOP	“10”

Description of analysis sets

Prespecified analysis populations

Analysis population	Definition excerpt
Full analysis population	“all subjects”
Safety population: exposure requirement	“at least 1 dose”

Sponsor-reported imputation for missing severity-index data

“last-observation-carry forward (LOCF)” (opens the source at this quote in a new tab)

Results

Participant disposition

Enrollment and completion

“Eight patients were enrolled and six completed the study.” (opens the source at this quote in a new tab)

Baseline characteristics

Baseline disease burden in the sponsor results table

Measure	Reported baseline
Modified Japanese Dermatology Association severity index	“9”
Body surface area with erythema and pustules	“24%”
DLQI	“16”

Efficacy results

CGI response at both week 4 and week 16

“Six of 8 (75%)” (opens the source at this quote in a new tab)

GPPPGA response in the subgroup assessed after protocol amendment

Measure	Reported value
Participants assessed	“4”
GPPPGA 0 or 1 at week 4	“2 (50%)”
GPPPGA 0 or 1 at week 16	“3 (75%)”

Health-related quality of life and patient-reported outcomes

DLQI change relative to baseline in the sponsor results table

Assessment	Change in score
Week 4	“-6”
Week 16	“-11”

Safety results

GALLOP: safety

“Two patients experienced serious adverse events (SAEs); no deaths were reported.” (opens the source at this quote in a new tab)

Serious Staphylococcal aureus bacteremia: investigator causality assessment

“possibly drug-related” (opens the source at this quote in a new tab)

Study limitations

Summary

GALLOP was open-label and single-arm, with eight participants enrolled and six completing the study. Without a randomized control group, observed improvement cannot establish the treatment effect separately from the natural course of a flare. GPPPGA results were reported for four participants after a protocol amendment, whereas CGI response used the full cohort. This limits comparison of the response percentages across instruments.