Subjects affected by non-segmental vitiligo MedDRA version: 14.1 Level: PT Classification code 10062080 Term: Pigmentation disorder System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
CLINUVEL PHARMACUETICALS LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement •Stable or slowly progressive vitiligo over a 3-month period •Aged 18 or more •Fitzpatrick skin types III-VI •Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator •Providing written Informed Consent prior to the performance of any study-specific procedure Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: •Fitzpatrick skin types I-II •Vitiligo involving the hands and feet only •Extensive leukotrichia, in the opinion of the Investigator •Vitiligo of more than 5 years duration • Previous treatment with NB-UVB within 6 months prior to the Screening Visit • Patient not responsive to previous NB-UVB treatment, defined as a patient who has undergone at least 30 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator •Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant •Previous treatment with topical immunomodulators (corticosteroids, calcineurin inhibitors) for vitiligo within 4 weeks prior to the Screening Visit •History of photosensitivity disorders •Claustrophobia •History of photosensitive lupus •Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator • Any disorder associated with an immune deficiency eg infections with EBV or CMV • Diagnosed with HIV/AIDS, or Hepatitis B or C •History of melanoma or lentigo maligna • Patients with a family history of melanoma in a first degree relative •History of dysplastic nevus syndrome • History of malignant or pre-malignant skin lesions • Patients with a large number of nevi or patients having more than 5 atypical nevi •Any skin disease that may interfere with the study evaluation •Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator •History of systemic or psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation •Female who is pregnant (confirmed by positive β-HCG pregnancy test) or lactating •Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) during the trial and for a period of three months thereafter •Sexually active man with a partner of child-bearing potential not using barrier contraception during the trial and for a period of three months hereafter •Participation in a clinical trial for an investigational agent within 30 days prior to the Screening Visit •Use of any prior and concomitant therapy which may interfere with the objective of the study, including drugs that cause photosensitivity or skin pigmentation within 60 days prior to the Screening Visit •Subjects assessed as not suitable for the study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of afamelanotide implants and NB-UVB light in the treatment of nonsegmental vitiligo;Secondary Objective: â?¢ To determine the short-term safety of both treatments in patients with nonsegmental vitiligo â?¢ To evaluate the maintenance of pigmentation achieved with both treatments in patients with nonsegmental vitiligo;Primary end point(s): The time to onset of repigmentation of full body, face, trunk and extremities from Day 0 to Day 168 between the two treatment groups. H0: there will be no difference in the time to onset of repigmentation of full body, face, trunk and extremities between the two treatment groups. The primary efficacy endpoint will be analyzed as soon as Day 168 data become available.;Timepoint(s) of evaluation of this end point: from Day 0 to Day 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Day 0 to Day 168 between each treatment group in: • The pigmentation of full body, face, trunk and extremities • The patient’s quality of life Change from Day 168 to Days 224, 280 and 336 between each treatment group in: • The pigmentation of full body, face, trunk and extremities;Timepoint(s) of evaluation of this end point: Change from Day 0 to Day 168 between each treatment group in: • The pigmentation of full body, face, trunk and extremities • The patient’s quality of life Change from Day 168 to Days 224, 280 and 336 between each treatment group in: • The pigmentation of full body, face, trunk and extremities | — |
Countries
Italy, Switzerland
Contacts
Public ContactClinical department
Clinuvel Pharmaceuticals Ltd
Outcome results
None listed