Trial Outcomes & Findings for A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis (NCT NCT00820950)

NCT ID: NCT00820950

Last Updated: 2022-02-08

Results Overview

The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline, Days 8, 15, 22, 28 and 56
• Results posted on: 2022-02-08

Participant Flow

The study was conducted at 6 study centers in the United States from 08 May 2007 to 28 April 2008. This study is completed.

A total of 29 participants with active but stable plaque psoriasis were enrolled in the 2 part dose escalation study; 27 participant completed the study. In Part 1, each participant treated 1 plaque with INCB018424 cream, and a matching plaque with vehicle cream. In Part 2, each participant treated 1 plaque with INCB018424 cream, and a matching plaque with a comparator drug cream.

Unit of analysis: Plaques

Participant milestones

Measure	Part 1 Cohort A: Vehicle Cream Vehicle cream was applied once a day for 28 days	Part 1 Cohort A Ruxolitinib 0.5% Cream Ruxolitinib 0.5% was applied once a day for 28 days	Part 1 Cohort B: Vehicle Cream Vehicle Cream was applied once a day for 28 days	Part 1 Cohort B Ruxolitinib 1.0% Cream Ruxolitinib 1.0% was applied once a day for 28 days	Part 1 Cohort C: Vehicle Cream Vehicle Cream was applied once a day for 28 days	Part 1 Cohort C Ruxolitinib 1.5% Cream Ruxolitinib 1.5% was applied once a day for 28 days	Part 2 Cohort D: INCB18424 up to 1/5% Ruolitinib cream was applied twice a day for 28 days	Part 2 Cohort D Calcipotriene (Dovonex®) Calcipotriene (Dovonex®) 0.005% cream was applied twice a day for 28 days	Part 2 Cohort E: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E Betamethasone Dipropionate (Diprolene® AF) Betamethasone Dipropionate (Diprolene® AF) 0.05% cream were applied twice a day for 28 days
Overall Study STARTED	6 6	6 6	6 6	6 6	6 6	6 6	6 6	6 6	5 5	5 5
Overall Study COMPLETED	5 5	5 5	6 6	6 6	6 6	6 6	5 5	5 5	5 5	5 5
Overall Study NOT COMPLETED	1 1	1 1	0 0	0 0	0 0	0 0	1 1	1 1	0 0	0 0

Reasons for withdrawal

Measure	Part 1 Cohort A: Vehicle Cream Vehicle cream was applied once a day for 28 days	Part 1 Cohort A Ruxolitinib 0.5% Cream Ruxolitinib 0.5% was applied once a day for 28 days	Part 1 Cohort B: Vehicle Cream Vehicle Cream was applied once a day for 28 days	Part 1 Cohort B Ruxolitinib 1.0% Cream Ruxolitinib 1.0% was applied once a day for 28 days	Part 1 Cohort C: Vehicle Cream Vehicle Cream was applied once a day for 28 days	Part 1 Cohort C Ruxolitinib 1.5% Cream Ruxolitinib 1.5% was applied once a day for 28 days	Part 2 Cohort D: INCB18424 up to 1/5% Ruolitinib cream was applied twice a day for 28 days	Part 2 Cohort D Calcipotriene (Dovonex®) Calcipotriene (Dovonex®) 0.005% cream was applied twice a day for 28 days	Part 2 Cohort E: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E Betamethasone Dipropionate (Diprolene® AF) Betamethasone Dipropionate (Diprolene® AF) 0.05% cream were applied twice a day for 28 days
Overall Study Scheduling Conflict	0	0	0	0	0	0	1	1	0	0
Overall Study Protocol Violation	1	1	0	0	0	0	0	0	0	0

Baseline Characteristics

A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

Baseline characteristics by cohort

Measure	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.0% cream vs. vehicle cream once a day for 28 days	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) n=6 Participants Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) n=5 Participants Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days	Total n=29 Participants Total of all reporting groups
Age, Continuous	42.2 Years STANDARD_DEVIATION 14.25 • n=93 Participants	48.8 Years STANDARD_DEVIATION 10.25 • n=4 Participants	55.8 Years STANDARD_DEVIATION 10.38 • n=27 Participants	50.2 Years STANDARD_DEVIATION 21.13 • n=483 Participants	46.2 Years STANDARD_DEVIATION 10.08 • n=36 Participants	48.7 Years STANDARD_DEVIATION 13.79 • n=10 Participants
Sex/Gender, Customized Male	4 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	4 Participants n=36 Participants	20 Participants n=10 Participants
Sex/Gender, Customized Female	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	1 Participants n=36 Participants	9 Participants n=10 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized White or Caucasian	5 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	6 Participants n=483 Participants	5 Participants n=36 Participants	27 Participants n=10 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants	5 Participants n=483 Participants	4 Participants n=36 Participants	26 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Days 8, 15, 22, 28 and 56

Population: Intent-to-Treat (ITT) population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts).

The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).

Outcome measures

Measure	Part 2 Cohort D: INCB18424 n=6 Participants up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort D: Calcipotriene (Dovonex®) n=6 Participants Calcipotriene (Dovonex®) 0.005% cream was applied twice a day	Part 2 Cohort E: INCB18424 n=5 Participants up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) n=5 Participants Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days	Part 1 Cohort A: Vehicle n=6 Participants placebo cream	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Vehicle n=6 Participants Placebo cream	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Vehicle Cream n=6 Participants Vehicle Placebo cream	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 8 - Erythema	-1.2 Scores on a scale Standard Deviation 1.10	-0.8 Scores on a scale Standard Deviation 0.84	-1.0 Scores on a scale Standard Deviation 0.82	-1.3 Scores on a scale Standard Deviation 0.96	-0.5 Scores on a scale Standard Deviation 0.84	-0.5 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.41	-1.0 Scores on a scale Standard Deviation 0.63	-0.7 Scores on a scale Standard Deviation 0.82	-1.2 Scores on a scale Standard Deviation 0.75
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 8 - Scaling	-0.6 Scores on a scale Standard Deviation 0.89	-0.6 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.50	-0.8 Scores on a scale Standard Deviation 0.50	-0.2 Scores on a scale Standard Deviation 0.41	-0.2 Scores on a scale Standard Deviation 0.41	0.0 Scores on a scale Standard Deviation 0.00	-0.2 Scores on a scale Standard Deviation 0.41	-0.7 Scores on a scale Standard Deviation 0.82	-1.2 Scores on a scale Standard Deviation 0.41
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 8 - Thickness	-0.4 Scores on a scale Standard Deviation 0.89	-0.6 Scores on a scale Standard Deviation 0.55	-0.5 Scores on a scale Standard Deviation 0.58	-0.8 Scores on a scale Standard Deviation 0.96	-0.7 Scores on a scale Standard Deviation 1.03	-0.7 Scores on a scale Standard Deviation 1.03	-0.2 Scores on a scale Standard Deviation 0.41	-0.3 Scores on a scale Standard Deviation 0.52	-0.3 Scores on a scale Standard Deviation 0.52	-0.8 Scores on a scale Standard Deviation 0.75
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 15 - Erythema	-1.0 Scores on a scale Standard Deviation 0.71	-0.8 Scores on a scale Standard Deviation 0.45	-1.0 Scores on a scale Standard Deviation 1.00	-1.2 Scores on a scale Standard Deviation 0.84	-0.7 Scores on a scale Standard Deviation 0.82	-0.7 Scores on a scale Standard Deviation 0.82	-0.8 Scores on a scale Standard Deviation 0.75	-1.0 Scores on a scale Standard Deviation 0.63	-0.5 Scores on a scale Standard Deviation 0.84	-1.2 Scores on a scale Standard Deviation 0.98
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 15 - Scaling	-0.2 Scores on a scale Standard Deviation 0.84	-0.4 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.45	-1.2 Scores on a scale Standard Deviation 0.45	-0.3 Scores on a scale Standard Deviation 0.52	-0.3 Scores on a scale Standard Deviation 0.52	-0.2 Scores on a scale Standard Deviation 0.75	-0.3 Scores on a scale Standard Deviation 0.82	-0.7 Scores on a scale Standard Deviation 0.82	-1.0 Scores on a scale Standard Deviation 0.00
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 15 - Thickness	-0.6 Scores on a scale Standard Deviation 1.14	-0.8 Scores on a scale Standard Deviation 0.84	-0.6 Scores on a scale Standard Deviation 1.14	-0.6 Scores on a scale Standard Deviation 0.89	-0.3 Scores on a scale Standard Deviation 0.52	-0.3 Scores on a scale Standard Deviation 0.52	-0.2 Scores on a scale Standard Deviation 0.41	-0.3 Scores on a scale Standard Deviation 0.52	-0.5 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.41
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 22 - Erythema	-1.8 Scores on a scale Standard Deviation 1.30	-1.0 Scores on a scale Standard Deviation 1.00	-1.4 Scores on a scale Standard Deviation 0.89	-1.6 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.84	-1.0 Scores on a scale Standard Deviation 0.71	-1.0 Scores on a scale Standard Deviation 0.63	-1.5 Scores on a scale Standard Deviation 0.84	-0.3 Scores on a scale Standard Deviation 0.82	-1.2 Scores on a scale Standard Deviation 0.98
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 22 - Scaling	-0.6 Scores on a scale Standard Deviation 1.14	-0.6 Scores on a scale Standard Deviation 0.89	-0.8 Scores on a scale Standard Deviation 0.45	-1.0 Scores on a scale Standard Deviation 0.71	-0.4 Scores on a scale Standard Deviation 0.55	-0.6 Scores on a scale Standard Deviation 0.55	-0.5 Scores on a scale Standard Deviation 0.55	-0.8 Scores on a scale Standard Deviation 0.75	-0.5 Scores on a scale Standard Deviation 0.84	-1.2 Scores on a scale Standard Deviation 0.41
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 22 - Thickness	-1.0 Scores on a scale Standard Deviation 1.00	-0.8 Scores on a scale Standard Deviation 0.45	-1.0 Scores on a scale Standard Deviation 0.71	-0.8 Scores on a scale Standard Deviation 0.84	-0.2 Scores on a scale Standard Deviation 1.10	-0.6 Scores on a scale Standard Deviation 0.89	-0.3 Scores on a scale Standard Deviation 0.52	-0.5 Scores on a scale Standard Deviation 0.84	-0.8 Scores on a scale Standard Deviation 0.75	-1.2 Scores on a scale Standard Deviation 0.75
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 28 - Erythema	-1.4 Scores on a scale Standard Deviation 1.14	-1.2 Scores on a scale Standard Deviation 0.84	-1.2 Scores on a scale Standard Deviation 0.84	-1.8 Scores on a scale Standard Deviation 0.84	-0.6 Scores on a scale Standard Deviation 0.55	-0.4 Scores on a scale Standard Deviation 0.55	-1.2 Scores on a scale Standard Deviation 0.41	-1.7 Scores on a scale Standard Deviation 0.52	-0.5 Scores on a scale Standard Deviation 0.55	-1.0 Scores on a scale Standard Deviation 0.63
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 28 - Scaling	-0.8 Scores on a scale Standard Deviation 1.10	-0.8 Scores on a scale Standard Deviation 0.84	-0.8 Scores on a scale Standard Deviation 0.45	-1.2 Scores on a scale Standard Deviation 0.84	-0.2 Scores on a scale Standard Deviation 0.45	-0.4 Scores on a scale Standard Deviation 0.55	-0.7 Scores on a scale Standard Deviation 0.52	-1.0 Scores on a scale Standard Deviation 0.63	-0.5 Scores on a scale Standard Deviation 0.55	-1.2 Scores on a scale Standard Deviation 0.41
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 28 - Thickness	-1.0 Scores on a scale Standard Deviation 1.00	-1.0 Scores on a scale Standard Deviation 0.00	-1.0 Scores on a scale Standard Deviation 0.71	-1.2 Scores on a scale Standard Deviation 0.45	-0.4 Scores on a scale Standard Deviation 0.55	-0.2 Scores on a scale Standard Deviation 0.45	-0.3 Scores on a scale Standard Deviation 0.52	-1.0 Scores on a scale Standard Deviation 0.63	-1.2 Scores on a scale Standard Deviation 0.75	-1.5 Scores on a scale Standard Deviation 0.55
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 56/ET - Erythema	-1.0 Scores on a scale Standard Deviation 0.63	-1.2 Scores on a scale Standard Deviation 1.47	0.2 Scores on a scale Standard Deviation 0.84	-0.6 Scores on a scale Standard Deviation 0.55	-0.5 Scores on a scale Standard Deviation 1.05	-0.3 Scores on a scale Standard Deviation 0.52	0.0 Scores on a scale Standard Deviation 0.63	-0.2 Scores on a scale Standard Deviation 0.41	-0.5 Scores on a scale Standard Deviation 0.84	-0.5 Scores on a scale Standard Deviation 0.84
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 56/ET - Scaling	-0.8 Scores on a scale Standard Deviation 0.75	-0.7 Scores on a scale Standard Deviation 1.21	-0.2 Scores on a scale Standard Deviation 0.84	-0.4 Scores on a scale Standard Deviation 0.89	-0.2 Scores on a scale Standard Deviation 0.41	-0.2 Scores on a scale Standard Deviation 0.41	0.3 Scores on a scale Standard Deviation 0.82	0.7 Scores on a scale Standard Deviation 0.82	-0.7 Scores on a scale Standard Deviation 0.82	-0.7 Scores on a scale Standard Deviation 0.82
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline Day 56/ET - Thickness	-1.2 Scores on a scale Standard Deviation 0.75	-1.0 Scores on a scale Standard Deviation 0.63	0.0 Scores on a scale Standard Deviation 0.71	-0.4 Scores on a scale Standard Deviation 0.55	-0.3 Scores on a scale Standard Deviation 0.52	-0.3 Scores on a scale Standard Deviation 0.52	0.0 Scores on a scale Standard Deviation 0.75	0.2 Scores on a scale Standard Deviation 0.75	-0.7 Scores on a scale Standard Deviation 1.03	-0.8 Scores on a scale Standard Deviation 0.98

PRIMARY outcome

Timeframe: Baseline, Days 8, 15, 22, 28 and 56

Population: ITT population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts)

The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).

Outcome measures

Measure	Part 2 Cohort D: INCB18424 n=6 Participants up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort D: Calcipotriene (Dovonex®) n=6 Participants Calcipotriene (Dovonex®) 0.005% cream was applied twice a day	Part 2 Cohort E: INCB18424 n=5 Participants up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) n=5 Participants Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days	Part 1 Cohort A: Vehicle n=6 Participants placebo cream	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Vehicle n=6 Participants Placebo cream	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Vehicle Cream n=6 Participants Vehicle Placebo cream	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline Day 28	-3.4 Score on Scale Standard Deviation 2.70	-3.2 Score on Scale Standard Deviation 1.30	-3.0 Score on Scale Standard Deviation 1.58	-4.2 Score on Scale Standard Deviation 1.79	-1.2 Score on Scale Standard Deviation 1.30	-1.0 Score on Scale Standard Deviation 1.41	-2.2 Score on Scale Standard Deviation 1.17	-3.8 Score on Scale Standard Deviation 1.60	-2.2 Score on Scale Standard Deviation 1.60	-3.7 Score on Scale Standard Deviation 1.37
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline Day 56/ET	-3.2 Score on Scale Standard Deviation 1.60	-3.0 Score on Scale Standard Deviation 2.90	0.0 Score on Scale Standard Deviation 2.00	-1.4 Score on Scale Standard Deviation 1.67	-1.5 Score on Scale Standard Deviation 1.87	-1.3 Score on Scale Standard Deviation 1.21	0.5 Score on Scale Standard Deviation 1.87	0.5 Score on Scale Standard Deviation 1.38	-1.8 Score on Scale Standard Deviation 2.23	-2.0 Score on Scale Standard Deviation 2.10
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline Day 8	-2.4 Score on Scale Standard Deviation 2.70	-2.2 Score on Scale Standard Deviation 1.79	-2.3 Score on Scale Standard Deviation 0.96	-2.8 Score on Scale Standard Deviation 1.71	-1.3 Score on Scale Standard Deviation 1.97	-1.3 Score on Scale Standard Deviation 1.21	-1.0 Score on Scale Standard Deviation 0.63	-1.7 Score on Scale Standard Deviation 1.37	-1.7 Score on Scale Standard Deviation 2.07	-3.2 Score on Scale Standard Deviation 1.72
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline Day 15	-2.0 Score on Scale Standard Deviation 2.55	-2.2 Score on Scale Standard Deviation 1.79	-2.4 Score on Scale Standard Deviation 2.07	-3.0 Score on Scale Standard Deviation 1.87	-1.3 Score on Scale Standard Deviation 1.75	-1.3 Score on Scale Standard Deviation 1.75	-1.3 Score on Scale Standard Deviation 2.07	-2.0 Score on Scale Standard Deviation 1.79	-1.7 Score on Scale Standard Deviation 2.07	-3.0 Score on Scale Standard Deviation 1.26
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline Day 22	-3.6 Score on Scale Standard Deviation 3.13	-2.6 Score on Scale Standard Deviation 1.82	-3.2 Score on Scale Standard Deviation 1.64	-3.4 Score on Scale Standard Deviation 1.67	-1.4 Score on Scale Standard Deviation 1.95	-2.2 Score on Scale Standard Deviation 1.79	-1.8 Score on Scale Standard Deviation 0.98	-3.0 Score on Scale Standard Deviation 2.00	-1.7 Score on Scale Standard Deviation 2.25	-3.5 Score on Scale Standard Deviation 1.76

PRIMARY outcome

Timeframe: 3 months

A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.

Outcome measures

Measure	Part 2 Cohort D: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort D: Calcipotriene (Dovonex®) Calcipotriene (Dovonex®) 0.005% cream was applied twice a day	Part 2 Cohort E: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days	Part 1 Cohort A: Vehicle n=6 Participants placebo cream	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Vehicle n=6 Participants Placebo cream	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=5 Participants Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Vehicle Cream n=5 Participants Vehicle Placebo cream	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
Number of Participants With Treatment Emergent Adverse Events	—	—	—	—	6 Participants	1 Participants	5 Participants	4 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Days 8, 15, 22, and 28

The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.

Outcome measures

Measure	Part 2 Cohort D: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort D: Calcipotriene (Dovonex®) Calcipotriene (Dovonex®) 0.005% cream was applied twice a day	Part 2 Cohort E: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days	Part 1 Cohort A: Vehicle n=6 Participants placebo cream	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Vehicle n=6 Participants Placebo cream	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Vehicle Cream n=5 Participants Vehicle Placebo cream	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
Pharmacokinetics Parameter : Skin Flux of INCB018424	—	—	—	—	54.2 ng/cm^2/h Standard Deviation 40.8	151 ng/cm^2/h Standard Deviation 70	422 ng/cm^2/h Standard Deviation 200	363 ng/cm^2/h Standard Deviation 215	383 ng/cm^2/h Standard Deviation 256	—

PRIMARY outcome

Timeframe: Days 8, 15, 22, and 28

The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.

Outcome measures

Measure	Part 2 Cohort D: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort D: Calcipotriene (Dovonex®) Calcipotriene (Dovonex®) 0.005% cream was applied twice a day	Part 2 Cohort E: INCB18424 up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days	Part 1 Cohort A: Vehicle n=6 Participants placebo cream	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Vehicle n=6 Participants Placebo cream	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Vehicle Cream n=5 Participants Vehicle Placebo cream	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
Pharmacokinetics Parameter : Bioavailability of INCB018424	—	—	—	—	2.8 Percentage of dosage Standard Deviation 3.2	3.0 Percentage of dosage Standard Deviation 1.9	3.0 Percentage of dosage Standard Deviation 1.9	2.7 Percentage of dosage Standard Deviation 1.1	2.7 Percentage of dosage Standard Deviation 2.3	—

SECONDARY outcome

Timeframe: Day 28

Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.

Outcome measures

Measure	Part 2 Cohort D: INCB18424 n=6 Participants up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort D: Calcipotriene (Dovonex®) n=6 Participants Calcipotriene (Dovonex®) 0.005% cream was applied twice a day	Part 2 Cohort E: INCB18424 n=5 Participants up to 1.5% Ruxolitinib cream was applied twice a day	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) n=5 Participants Betamethasone Dipropionate (Diprolene® AF) 0.05% cream was applied twice a day for 28 days	Part 1 Cohort A: Vehicle n=6 Participants placebo cream	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Vehicle n=6 Participants Placebo cream	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Vehicle Cream n=6 Participants Vehicle Placebo cream	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n=6 Participants Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days
Change in Target Lesion Area Compared to Baseline	-5.22 cm^2 Standard Deviation 6.203	-2.54 cm^2 Standard Deviation 6.778	1.53 cm^2 Standard Deviation 1.624	-0.48 cm^2 Standard Deviation 5.892	0.35 cm^2 Standard Deviation 4.872	1.53 cm^2 Standard Deviation 9.760	0.45 cm^2 Standard Deviation 3.775	-3.18 cm^2 Standard Deviation 8.651	-4.03 cm^2 Standard Deviation 12.303	-11.45 cm^2 Standard Deviation 13.851

Adverse Events

Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n=6 participants at risk Ruxolitinib 0.5% vs. vehicle cream once a day for 28 days	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n=6 participants at risk Ruxolitinib 1.0% cream once a day for 28 days	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n=6 participants at risk Ruxolitinib 1.5% vs. vehicle cream twice a day for 28 days	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) n=6 participants at risk Ruxolitinib up to 1.5% versus Calcipotriene (Dovonex®) 0.005% cream applied twice a day for 28 days	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) n=5 participants at risk Part 2 INCB018424, up to 1.5% cream versus Betamethasone Dipropionate (Diprolene® AF) 0.05% cream applied twice a day for 28 days	Total n=29 participants at risk Total
General disorders APPLICATION SITE REACTION	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	20.0% 1/5 • Number of events 3 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	10.3% 3/29 • Number of events 5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	20.0% 1/5 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	6.9% 2/29 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations ELECTROCARDIOGRAM QT INTERVAL ABNORMAL	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	20.0% 1/5 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	20.0% 1/5 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations ELECTROCARDIOGRAM T WAVE ABNORMAL	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	20.0% 1/5 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	6.9% 2/29 • Number of events 3 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
General disorders FEELING COLD	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 3 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 3 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations HAEMATOCRIT DECREASED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Nervous system disorders HEADACHE	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Infections and infestations NASOPHARYNGITIS	33.3% 2/6 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	6.9% 2/29 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
General disorders PAIN	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Skin and subcutaneous tissue disorders PRURITUS	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	13.8% 4/29 • Number of events 4 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Skin and subcutaneous tissue disorders RASH PRURITIC	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations RETICULOCYTE COUNT INCREASED	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	20.0% 1/5 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	6.9% 2/29 • Number of events 4 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Skin and subcutaneous tissue disorders SKIN IRRITATION	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Injury, poisoning and procedural complications SUNBURN	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	33.3% 2/6 • Number of events 2 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	10.3% 3/29 • Number of events 3 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.
Investigations URINE KETONE BODY PRESENT	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/6 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	16.7% 1/6 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	0.00% 0/5 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.	3.4% 1/29 • Number of events 1 • Up to approximately 2 months Adverse Events were reported at the participant level, not the treatment level within each cohort.

Additional Information

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