A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.

Time frame: Week 16

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders. Participants who discontinued study intervention due to lack of efficacy or Adverse event (AE) of worsening of hidradenitis suppurativa (HS), or who started protocol-prohibited medication or therapy during study that could improve HS were considered treatment failures.

DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicates improvement in the Quality of Life.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 \[no improvement\] if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours with a score range from 0 (no symptom experience) to 10 (worst possible symptom experience). A total symptom score also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. Change from baseline in HS-related pain symptom score based on HSSD was reported.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants who received analgesic therapy for HS within 1 day of a scheduled visit date, the participants were considered a treatment failure at that visit (the change from baseline using observed data or 0 \[no improvement\] if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Change from baseline in hs-CRP at Week 16 was reported. Serum samples were collected and analyzed for hsCRP. Change from Baseline was calculated as: (\[hs-CRP value at Week 16 minus Baseline value\] divided by \[Baseline value\]).

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

The HADS has been developed to identify symptoms of anxiety and depression in hospitalized participants and in outpatients. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (\>) 9 = anxiety; HADS (depression): 0-8 = no depression; \>9 = depression.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 \[no improvement\] if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. Change from baseline in each individual HSSD component scale (other than pain in the past 24 hours) tenderness, hot skin feeling, odor and itchiness symptom, pain, and current pain score (rated on a scale of 0 \[no symptom experience\] to 10 \[worst possible symptom experience\]) were reported.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least 1 dose of study intervention. Analysis was based on observed data after applying TF rules (change from baseline using observed data or 0 \[no improvement\] if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure and n (number of participants analyzed) signifies participants who were evaluated for this outcome measure for specified categories.

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. A total symptom score, also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 (no improvement) if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Change from baseline in number of draining fistulas at Week 16 was reported. Draining fistula are defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 \[no improvement\] if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure.

Change from baseline in number of inflammatory nodules at Week 16 was reported.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 (no improvement) if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 \[no improvement\] if a participant met treatment failure \[TF\] criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Change from baseline in number of abscesses at Week 16 was reported.

Time frame: Baseline and Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 (no improvement) if a participant met TF criteria). Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

The PGIC of HS Severity is a questionnaire that measures participants' perceived change (improvement or deterioration) in severity of their HS. Participants rated how his/her HS has changed since the beginning of the study using a 7-point scale ranging from 1 which indicates a lot better now to 7 which indicates a lot worse now with a neutral center point 4 which indicates (neither better nor worse). Participants' PGIC of HS Severity scale score at Week 16 were reported

Time frame: Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules are assumed to be 'Not improved'. Here, N (number of participants analyzed) signifies participants who were evaluated for this outcome measure.

Percentage of participants who achieved 100 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved abscess count of 0 at Week 16 for participants with baseline abscess count greater than (\>) 0 were reported.

Time frame: Week 16

Population: Population analyzed included FAS participants with baseline abscess count \> 0. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved an AN count of 0/1 and AN Count of 0/1/2 at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved at least 50 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Week 16

Population: FAS included all randomized participants who receive at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved at least 75 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved at least 90 percent reduction in total AN count at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Time frame: Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved draining fistulas count of 0 at Week 16 for participants with baseline draining fistula count \>0 were reported. Draining fistula were defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

Time frame: Week 16

Population: Population analyzed included FAS participants with baseline draining fistula count \> 0. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

Percentage of participants who achieved inflammatory nodules count of 0 at Week 16 in participants with baseline inflammatory nodules count \>0 were reported.

Time frame: Week 16

Population: Population analyzed included FAS participants with baseline inflammatory nodule count \> 0. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 were reported.

Time frame: Week 16

Population: FAS included all randomized participants who received at least one administration of study intervention. Participants with missing data after applying treatment failure rules were assumed to be non-responders.

The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. Among participants with score of moderate activity (3) or severe activity (4) at baseline, the same anatomic site selected for evaluation at the baseline were re-evaluated at Week 16. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1) at Week 16 among participants with HS-IGA score of moderate activity (3) or severe activity (4) at baseline were reported.

Time frame: Week 16

Population: Population analyzed included FAS participants with HS-IGA scores of moderate activity (3) or severe activity (4) at baseline. Participants with missing data after applying treatment failure rules were assumed to be non-responders.