A long-term study to assess the safety and efficacy of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10037084Term: Prurigo nodularisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Prurigo Nodularis
- Registration Number
- EUCTR2019-004294-13-IT
- Lead Sponsor
- Galderma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
1. Subjects who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including:
a. Subjects who completed the treatment period (Week 16 visit) in a phase 3 pivotal study (RD.06.SPR.202685 or RD.06.SPR.203065) and enroll within 56 days OR
b. Subjects who completed the nemolizumab phase 2a PN study (RD.03.SPR.115828).
2. Female subjects of childbearing potential must agree to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below:
• True abstinence, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
• Progestogen-only oral hormonal contraception;
• Combination of male condom with cap, diaphragm, or sponge with spermicide (double barrier methods);
• Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception;
• Injectable or implanted hormonal contraception;
• Intrauterine devices;
• Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study;
• Vasectomy of partner at least 3 months before the study;
3. Female subjects of non-childbearing potential must meet one of the following criteria:
• Absence of menstrual bleeding for 1 year prior to screening without any other medical reason; OR
• Documented hysterectomy or bilateral oophorectomy at least 3 months before the study.
4. Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the subject using an electronic handheld device provided for this study;
5. Understand and sign an informed consent form before any investigational procedure(s) are performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 268
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132
1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject;
2. Body weight < 30 kg;
3. Having received any of the treatments listed in Table 2 in the protocol within the specified timeframe before the baseline visit:
4. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study;
5. Any medical or psychological condition that may put the subject at significant risk according to the PI's judgment, if he/she participates in the clinical study, or may interfere with study assessments;
6. Planning or expected to have a major surgical procedure during the clinical study;
7. Subjects unwilling to refrain from using prohibited medications during the clinical study;
8. History of alcohol or substance abuse within 6 months of the screening visit.
9. Subjects with a history of asthma meeting 1 or more of the following criteria:
a. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months;
b. Reporting asthma that has not been well-controlled during the preceding 3 months;
c. Asthma Control Test =19
d. Peak expiratory flow <80% of the predicted value.
10. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis;
11. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit.
12. Positive serology results HBsAg or HBcAb, hepatitis C antibody, or HIV antibody at screening;
13. Chronic pruritus resulting from another active condition than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus,
habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease;
14. History of or current confounding skin condition, chronic actinic dermatitis, dermatitis herpetiformis);
15. Subjects with active atopic dermatitis in the last 3 months;
16. Neuropathic and psychogenic pruritus,
17. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for: (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the screening visit, or (2) actinic keratoses that have been treated;
18. History of hypersensitivity to an immunoglobulin or to any of the study drug excipients;
19. Known active or latent tuberculosis infection;
20. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per PI judgment;
21. Any clinically relevant laboratory abnormalities, such as elevated ALT or AST (>3 × upper limit of normal [ULN]) in combination with elevated bilirubin (>2 × ULN), during the screening period that may put the subject at significant risk according to the investigator's judgment, if he/she participates in the clinical study;
22. Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period from a previous study, other than the
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the long-term safety of nemolizumab (CD14152) in subjects with prurigo nodularis (PN).;Secondary Objective: The secondary objective is to assess the long-term efficacy of nemolizumab (CD14152) in subjects with PN.;Primary end point(s): Incidence and severity of adverse events (AEs), including AEs of special interest, treatment-emergent AEs, and serious AEs.;Timepoint(s) of evaluation of this end point: Throughout the study
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: As specified within the list of endpoints