4-[3-(cyanomethyl)-3-(3',5'-dimethyl-1H,1'H-[4,4'-bipyrazol]-1-yl)azetidin-1-yl]-2,5-difluoro-N-[(2S)-1,1,1-trifluoropropan-2-yl]benzamide for Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- Ability to comprehend and willingness to sign a written ICF for the study.\n- Completed the 54-week treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302) without safety concerns, per investigator's assessment.\n- Has demonstrated compliance, as assessed by the investigator, with the procedures described in the study Protocol of the originating parent study.\n- Agreement to use contraception, as per section 5.1.4 of the protocol.\n- Willing and able to comply with the study Protocol and procedures."}

Exclusion criteria

• {"criterion_text":"- Had been permanently discontinued from study treatment during the originating parent study.\n- Had any treatment-related Grade 3 or higher adverse event, or any treatment-related serious adverse event during the originating parent study that would, in the investigator's assessment, pose a significant risk to the participant's safety in this LTE study.\n- Had temporary study drug interruption at the final visit of the originating parent study and, in the opinion of the investigator, participation in this LTE study would pose an unacceptable risk to participant.\n- Any condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the Protocol.\n- Women who are pregnant (or who are considering pregnancy) or breastfeeding.\n- Plans for administration of a live, attenuated vaccine during the course of the study or within 8 weeks after the last dose of study drug.\n- Any condition or laboratory result during the originating parent study that, in the investigator's and sponsor's (or designee's) judgment, may interfere with full participation in this LTE study, including administration of study drug and attending required study visits, may pose a significant risk to the participant, or may interfere with interpretation of study data.\n- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants with treatment-emergent adverse events (TEAEs).","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with serious TEAEs.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with serious TEAEs leading to study drug discontinuation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants who achieve HiSCR at each visit. − HiSCR is defined as at least a 50% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.","definition_or_measurement_approach":"HiSCR defined in endpoint text: ≥50% reduction from parent-study baseline in total abscess and inflammatory nodule (AN) count, with no increase from parent-study baseline in abscess or draining tunnel count."}
• {"endpoint_text":"- Proportion of participants who achieve HiSCR75 at each visit. − HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.","definition_or_measurement_approach":"HiSCR75 defined in endpoint text: ≥75% reduction from parent-study baseline in total AN count, with no increase from parent-study baseline in abscess or draining tunnel count."}
• {"endpoint_text":"- Proportion of participants who achieve HiSCR90 at each visit. − HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.","definition_or_measurement_approach":"HiSCR90 defined in endpoint text: ≥90% reduction from parent-study baseline in total AN count, with no increase from parent-study baseline in abscess or draining tunnel count."}
• {"endpoint_text":"- Proportion of participants who achieve HiSCR100 at each visit. − HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.","definition_or_measurement_approach":"HiSCR100 defined in endpoint text: 100% reduction from parent-study baseline in total AN count, with no increase from parent-study baseline in abscess or draining tunnel count."}
• {"endpoint_text":"- Proportion of participants with flare at each visit. − Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 Ans relative to Week 54.","definition_or_measurement_approach":"Flare defined in endpoint text: ≥25% increase in AN count with a minimum increase of 2 ANs relative to Week 54."}
• {"endpoint_text":"- Time to first flare.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mean change from baseline of parent study in HiSQoL score at each visit. − The HiSQoL is a 17-item, HS-specific, health-related QoL instrument with a 7‐day recall period. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.","definition_or_measurement_approach":"Mean change from parent-study baseline in HiSQoL total score (0–68), HiSQoL described in endpoint text."}
• {"endpoint_text":"- Mean change from baseline of parent study in DLQI at each visit. − The DLQI is a skin disease–specific questionnaire aimed at the evaluation of how the disease affects health-related QoL. The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QoL.","definition_or_measurement_approach":"Mean change from parent-study baseline in Dermatology Life Quality Index (DLQI) total score (0–30), as described in endpoint text."}
• {"endpoint_text":"- Proportion of participants with no increase in AN count relative to Week 54 at each visit.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with no increase in ANdT count relative to Week 54 at each visit. − ANdT count is defined as the total sum of abscess, inflammatory nodule, and draining tunnel.","definition_or_measurement_approach":"ANdT defined in endpoint text as sum of abscess, inflammatory nodule and draining tunnel; proportion with no increase relative to Week 54."}
• {"endpoint_text":"- Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with a total AN count of 0, 1, or 2 at each visit.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit.","definition_or_measurement_approach":""}

Primary sponsor

Full Name

Incyte Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Multiple operational sponsor duties (codes: 1,11,12,2,5,6) per dossier

Name

IQVIA RDS Hellas Single Member S.A.

Responsibilities

Operational duties (codes: 1,12)

Name

Q Squared Solutions Limited / Q Squared Solutions LLC

Responsibilities

Operational/lab support (sponsorDuties code: 4); local laboratory/operational support

Name

Medidata Solutions Inc.

Responsibilities

Platform/technology services (sponsorDuties code: 7)

Name

Suvoda LLC

Responsibilities

Operational support (sponsorDuties code: 3)

Third parties

• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: 15; Hidradenitis Suppurativa training recording/ training platform","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 11, 12, 2, 5, 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: 15; Patient or subject reimbursement as approved by sponsor","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 15; Electronic clinical outcome assessment (eCOA)","organisation_type":"Non-Pharmaceutical company"}