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This is a randomized, double-blind, multicenter, placebo-controlled clinical study intended to evaluate the efficacy, safety and population pharmacokinetic profiles of MH004 ointment in eligible participants with NSV.
The study consists of a screening period, a treatment period and a follow-up period, with the treatment period divided into two phases. In Double-blind Treatment Phase (24 weeks, D1 to W24), participants will be randomized at a 2:1 ratio to receive either MH004 ointment or placebo. And in Extended Treatment Phase (28 weeks, W25 to W52), after all participants complete all assessments prior to dosing at W24, they will enter the extended treatment phase and receive 1.0% MH004 ointment with the same dosing regimen as that in the double-blind treatment phase, administered twice daily (BID) until W52. Upon completion of study treatment, all participants will enter a 4-week safety follow-up period. The primary objective of this trial is the proportion of participants achieving at least a 75% improvement from baseline in the Facial Vitiligo Area Scoring Index at Week 24 (F-VASI75).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Masked Period: MH004 1.0% Ointment | Experimental | Participants received MH004 1.0% Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period. |
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| Double-Masked Period: MH004 Placebo | Placebo Comparator | Participants received MH004 Placebo Ointment topically twice a day (BID) from Day 1 to Week 24 during the Double-Masked Period. |
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| Extended Treatment Period: MH004 1.0% Ointment | Experimental | Participants received MH004 1.0%Ointment twice a day (BID) from Week 25 to Week 52 during the Extended Treatment Period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MH004 1.0% Ointment | Drug | MH004 1% ointment applied topically to the affected area as a thin film twice a day (BID). |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at least a 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24 (W24) | An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at least a 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI50) at Week 24 (W24) | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
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Inclusion Criteria:
Exclusion Criteria:
All terminal hairs (i.e., beard, eyebrows, eyelashes) within facial vitiligo areas are depigmented white.
Other subtypes of vitiligo or hypopigmentary disorders
Specific prior treatment history:
Treatments administered within the required washout period
Use of biologic agents within 12 weeks or 5 half-lives (whichever is longer) prior to the first study drug administration;
Receipt of laser therapy or any form of phototherapy (including tanning beds) within 8 weeks prior to the first study drug administration;
Within 4 weeks prior to the first study drug administration:
Systemic immunomodulators (e.g., corticosteroids, methotrexate, cyclosporine, etc.); Systemic medications that may affect vitiligo (e.g., melanocyte-stimulating agents, tetracyclines, methoxsalen, etc.); Administration of live or live-attenuated vaccines;
Oral traditional Chinese medicines for vitiligo within 2 weeks prior to the first study drug administration;
Topical agents applied to vitiligo lesions within 1 week prior to the first study drug administration (e.g., corticosteroids, calcineurin inhibitors, PDE4 inhibitors, retinoids, vitamin D3 analogues, or topical Chinese herbal preparations);
Temporary tattoos within vitiligo lesions within 30 days before the first dose (excluding vinyl adhesive tattoos), or any permanent tattoos previously placed within vitiligo lesions.
Concomitant diseases or medical history that may interfere with the study
Specific risks of cardiovascular and thromboembolic events
Active or latent infections
Positive virology screening results at screening
History of malignancy
Clinically significant abnormal laboratory values
Subjects planning major invasive procedures during the study, or with prior or planned organ transplantation requiring long-term immunosuppressants (e.g., kidney or liver transplantation).
Planned administration of live or live-attenuated vaccines during the study period.
Female subjects who are pregnant or breastfeeding.
Participation in another interventional drug clinical trial within 3 months or at least 5 half-lives (whichever is longer) prior to randomization; or participation in a medical device clinical trial within 3 months prior to randomization.
Hypersensitivity and intolerance Known hypersensitivity to the investigational product or any excipient components.
Other exclusion factors
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CMO/ Senior Vice President of R&D | Contact | + 86 0571-86963293 | jwshi@minghuipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Double-Masked
| MH004 Placebo Ointment | Drug | MH004 Placebo ointment applied topically to the affected area as a thin film twice a day (BID). |
|
| Baseline; Week 24 |
| Proportion of participants achieving at least a 90% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI90) at Week 24 (W24) | An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). | Baseline; Week 24 |
| Proportion of participants achieving at least a 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI50) at Week 24 (W24) | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). | Baseline; Week 24 |
| Proportion of participants achieving at least a 75% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI75) at Week 24 (W24) | A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). | Baseline; Week 24 |
| Proportion of participants achieving at least a 90% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI90) at Week 24 (W24) | A T-VASI90 responder achieved at least 90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). | Baseline; Week 24 |
| Proportion of participants achieving F-VASI75 at Week 52 (W52) | An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). | Baseline; Week 52 |
| Proportion of participants achieving T-VASI75 at Week 52 (W52) | A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). | Basline; Week 52 |
| Percentage change from baseline in F-VASI score at Week 24 | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 24 |
| Percentage change from baseline in F-VASI score at Week 52 | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Percentage change from baseline in T-VASI score at Week 24 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 24 |
| Percentage change from baseline in T-VASI score at Week 52 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Percentage change from baseline in facial body surface area (F-BSA) score at Week 24 (W24) | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100. | Baseline; Week 24 |
| Percentage change from baseline in total body surface area (T-BSA) score at Week 24 (W24) | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 24 |
| Proportion of participants achieving F-VASI50 at Week 52 (W52) | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). | Baseline; Week 52 |
| Proportion of participants achieving F-VASI90 at Week 52 (W52) | An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). | Baseline; Week 52 |
| Proportion of participants achieving T-VASI50 at Week 52 (W52) | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). | Basline; Week 52 |
| Proportion of participants achieving T-VASI90 at Week 52 (W52) | A T-VASI90 responder achieved at least 90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). | Basline; Week 52 |
| Percentage change from baseline in facial body surface area (F-BSA) score at Week 52 (W52) | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Percentage change from baseline in total body surface area (T-BSA) score at Week 52 (W52) | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-BL value minus BL value]/BL value) X 100. | Baseline; Week 52 |
| Incidence, Frequency, Duration and Severity of Treatment-Emergent Adverse Event (TEAE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug. | From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 56) |
| Incidence of Treatment-Emergent Serious Adverse Event (SAE) and Incidence of AEs resulting discontinue medication | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or an important medical event may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. A TEAE or treatment emergent SAE is any AE or SAE either reported for first time or worsening of a pre-existing event after first dose of study drug. | From the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 56) |