A Phase 2 interventional study of Ruxolitinib cream and Vehicle cream in Cutaneous Lichen Planus, sponsored by Incyte Corporation. Completed at 24 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's enrollment of 64 is above the median of 30 across 55 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Concurrent conditions and history of other diseases:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ruxolitinib 1.5% cream BID for 16 weeks, followed by ruxolitinib cream BID 16-week open-label extension.
Drug: Ruxolitinib cream · Drug: Vehicle cream
Vehicle cream BID for 16 weeks, followed by ruxolitinib 1.5% cream BID in a 16-week open-label extension.
Drug: Vehicle cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Also known as: INCB018424 cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.
Time frame: Baseline; Week 16
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
Time frame: Baseline; Weeks 2, 4, 8, 12, and 16
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
Time frame: Baseline; Weeks 18, 20, 24, 28, and 32
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: Baseline; Weeks 2, 4, 8, 12, and 16
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: Baseline; Weeks 18, 20, 24, 28, and 32
Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: up to Week 16
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 2, 4, 8, 12, and 16
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 18, 20, 24, 28, and 32
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Baseline to Week 16 plus 30 days
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Baseline to Week 16 plus 30 days
Number of Participants With Any TEAE During the Open-label Extension Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Week 17 to Week 32 plus 30 days
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Week 17 to Week 32 plus 30 days
| Milestone | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|---|---|
| Started | 32 | 32 | 0 | 0 |
| Completed | 30 | 29 | 0 | 0 |
| Not completed | 2 | 3 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 | 0 | 0 |
| Milestone | Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|---|---|
| Started | 0 | 0 | 30 | 29 |
| Completed | 0 | 0 | 29 | 23 |
| Not completed | 0 | 0 | 1 | 6 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 3 |
The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.
| percentage of participants | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16 | 50.0 (31.9 to 68.1) | 21.9 (9.3 to 40.0) |
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
| percentage of participants | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Week 2 | 9.7 (2.0 to 25.8) | 6.5 (0.8 to 21.4) |
| Week 4 | 25.8 (11.9 to 44.6) | 13.3 (3.8 to 30.7) |
| Week 8 | 51.6 (33.1 to 69.8) | 12.9 (3.6 to 29.8) |
| Week 12 | 53.3 (34.3 to 71.7) | 24.1 (10.3 to 43.5) |
| Week 16 | 53.3 (34.3 to 71.7) | 24.1 (10.3 to 43.5) |
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
| percentage of participants | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|
| Week 18 | 58.6 (38.9 to 76.5) | 25.0 (10.7 to 44.9) |
| Week 20 | 62.1 (42.3 to 79.3) | 33.3 (16.5 to 54.0) |
| Week 24 | 58.6 (38.9 to 76.5) | 44.0 (24.4 to 65.1) |
| Week 28 | 58.6 (38.9 to 76.5) | 45.8 (25.6 to 67.2) |
| Week 32 | 60.0 (40.6 to 77.3) | 60.9 (38.5 to 80.3) |
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
| percentage of participants | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Week 2 | 21.4 (8.3 to 41.0) | 3.3 (0.1 to 17.2) |
| Week 4 | 44.8 (26.4 to 64.3) | 7.1 (0.9 to 23.5) |
| Week 8 | 53.8 (33.4 to 73.4) | 7.4 (0.9 to 24.3) |
| Week 12 | 52.0 (31.3 to 72.2) | 12.0 (2.5 to 31.2) |
| Week 16 | 57.7 (36.9 to 76.6) | 19.2 (6.6 to 39.4) |
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
| percentage of participants | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|
| Week 18 | 72.7 (49.8 to 89.3) | 48.0 (27.8 to 68.7) |
| Week 20 | 73.9 (51.6 to 89.8) | 63.6 (40.7 to 82.8) |
| Week 24 | 79.2 (57.8 to 92.9) | 76.2 (52.8 to 91.8) |
| Week 28 | 86.4 (65.1 to 97.1) | 76.5 (50.1 to 93.2) |
| Week 32 | 84.2 (60.4 to 96.6) | 73.3 (44.9 to 92.2) |
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
| days | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period | 17.0 (7.0 to 27.0) | 97.0 (31.0 to NA) |
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| scores on a scale | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Baseline | 4.86 ± 2.303 | 4.51 ± 2.618 |
| Week 2 | -1.69 ± 2.047 | -0.55 ± 0.975 |
| Week 4 | -2.64 ± 2.307 | -0.69 ± 1.261 |
| Week 8 | -2.96 ± 2.622 | -0.95 ± 1.385 |
| Week 12 | -3.01 ± 2.823 | -0.84 ± 1.613 |
| Week 16 | -3.02 ± 2.656 | -1.25 ± 2.263 |
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| scores on a scale | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|
| Baseline | 4.86 ± 2.303 | 4.51 ± 2.618 |
| Week 18 | -3.65 ± 2.086 | -2.46 ± 2.253 |
| Week 20 | -3.81 ± 2.079 | -2.96 ± 2.584 |
| Week 24 | -3.82 ± 2.385 | -3.13 ± 2.868 |
| Week 28 | -3.99 ± 2.272 | -3.54 ± 3.145 |
| Week 32 | -4.25 ± 2.276 | -3.51 ± 3.470 |
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
| Participants | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | 15 | 9 |
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
| Participants | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID |
|---|---|---|
| Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | 0 | 0 |
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
| Participants | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|
| Number of Participants With Any TEAE During the Open-label Extension Period | 8 | 11 |
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
| Participants | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID |
|---|---|---|
| Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | 0 | 1 |
Collected over from Baseline to Week 32 plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Cream BID | 0/32 (0%) | 0/32 (0%) | 6/32 (18.8%) |
| Ruxolitinib Cream 1.5% BID | 0/60 (0%) | 0/60 (0%) | 14/60 (23.3%) |
| Event | Vehicle Cream BID | Ruxolitinib Cream 1.5% BID |
|---|---|---|
| NasopharyngitisInfections and infestations | 1/32 | 5/60 |
| HypothyroidismEndocrine disorders | 2/32 | 0/60 |
| COVID-19Infections and infestations | 1/32 | 3/60 |
| SinusitisInfections and infestations | 1/32 | 3/60 |
| Upper respiratory tract infectionInfections and infestations | 0/32 | 3/60 |
| Urinary tract infectionInfections and infestations | 1/32 | 3/60 |
| Age, Continuous(years) | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Total |
|---|---|---|---|
| Mean | 56.3 ± 14.35 | 58.2 ± 10.86 | 57.3 ± 12.66 |
| Sex: Female, Male(Participants) | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Total |
|---|---|---|---|
| Female | 22 | 24 | 46 |
| Male | 10 | 8 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 31 | 31 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID | Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID | Total |
|---|---|---|---|
| White/Caucasian | 21 | 19 | 40 |
| Black/African-American | 9 | 9 | 18 |
| Asian | 2 | 2 | 4 |
| Biracial | 0 | 1 | 1 |
| Mixed Race | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement
Data sharing details ↗ · www.incyte.com
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ruxolitinib