GEMINI-2

16 evidence topics · 7 sources

Objective

Primary objective

“long-term safety of imsidolimab” (opens the source at this quote in a new tab)

Location and study date

GEMINI-2: follow-up reported with the initial extension results

“Patients were followed for at least 24 weeks and up to a maximum of 92 weeks.” (opens the source at this quote in a new tab)

Study design

Treatment assignment according to response in GEMINI-1

“Treatment in GEMINI-2 was based on their responder status in GEMINI-1” (opens the source at this quote in a new tab)

Safety follow-up described in the subsequent publication

“evaluating the safety of imsidolimab up to 104 weeks” (opens the source at this quote in a new tab)

Eligibility criteria

Prior participation requirement

“have participated in the ANB019-301 study” (opens the source at this quote in a new tab)

Treatment

Randomized maintenance treatment for initial responders

“imsidolimab 200 mg or placebo every 4 weeks starting on Day 1.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using adverse event incidence as the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

GEMINI-2: sample size and power

“No formal sample size or power calculations were performed for this extension study.” (opens the source at this quote in a new tab)

Description of analysis sets

GEMINI-2: statistical hypothesis

“There is no formal statistical hypothesis.” (opens the source at this quote in a new tab)

Prespecified analysis populations

Analysis population	Definition excerpt
Intention-to-treat population	“all enrolled subjects”
Modified intention-to-treat population: previous response threshold	“GPPPGA score of 0 [clear] or 1 [almost clear]”
Extension safety population: treatment exposure requirement	“received at least one dose of imsidolimab or placebo”

Planned comparison of categorical efficacy outcomes

“Farrington-Manning score test” (opens the source at this quote in a new tab)

Results

Participant disposition

Extension enrollment and treatment groups

Population	Participants
Rolled over from GEMINI-1	“42”
Initial responders randomized to imsidolimab maintenance	“8”
Initial responders randomized to placebo maintenance	“8”
Partial responders receiving imsidolimab maintenance	“12”
Placebo nonresponders receiving IV rescue followed by SC maintenance	“9”
Imsidolimab nonresponders receiving other available therapy	“5”

Baseline characteristics

No evidence found.

Efficacy results

GEMINI-2: maintenance and flare prevention

Endpoint	“Imsidolimab (n=8)”	“PBO (n=8)”
“GPPPGA score of 0/1”	“100%”	“25%”
“flared (GPPPGA ≥3)”	“0”	“62.5%”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

GEMINI-2: serious adverse events and discontinuation

“No SAEs led to study treatment discontinuation/withdrawal” (opens the source at this quote in a new tab)

GEMINI-2: infusion reactions

“No infusion reactions reported” (opens the source at this quote in a new tab)

GEMINI-2: immunogenicity

“low incidence of anti-drug antibodies” (opens the source at this quote in a new tab)

Study limitations

Summary

The randomized maintenance comparison included 16 initial responders, eight per group, rather than all 42 extension participants. Its results therefore apply to a responder-enriched population. Other extension groups received nonrandomized treatment according to prior response. The statistical analysis plan specified no formal hypothesis and no formal sample size or power calculation. The small randomized groups limit precision for flare prevention and uncommon adverse events.