A study to assess the durability of effect and safety of nemolizumab (CD14152) in subjects with prurigo nodularis (PN)

Phase 1

Conditions: Prurigo Nodularis
MedDRA version: 20.0Level: LLTClassification code 10037084Term: Prurigo nodularisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2021-003928-32-PL

Lead Sponsor: Galderma S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Individuals must meet all the following criteria to be included in the study:
1. Subjects who achieved a clinical response at Week 52 of the LTE study RD.06.SPR.202699, defined as:
• IGA score of 0 (clear) or 1 (almost clear)
AND
• =4 point improvement in weekly average of PP NRS score from baseline of the lead-in study;
Note: Lead-in study baseline is defined as baseline PP NRS score in Phase 3 studies RD.06.SPR.202685 or RD.06.SPR.203065 for subjects who rolled over into the LTE from these studies. For subjects who entered the LTE study from the Phase 2 study RD.03.SPR.115828, the baseline PP NRS score at entry into the LTE study RD.06.SPR.202699 will be used;
2. Subjects with uninterrupted dosing of nemolizumab in the LTE study RD.06.SPR.202699 for 3 months before the Week 52 visit;
3. Subjects willing and able to transfer into the study at the time of completion of the Week 52 visit in the LTE study RD.06.SPR.202699;
4. Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile) 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 (e.g., 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) (*In Germany only, double barrier methods are not considered an adequate and approved method of contraception),
Note: Double barrier methods” refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (e.g., condom) with a spermicide is not acceptable.
• Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception,
• Injectable or implanted hormonal contraception,
• Intrauterine devices or intrauterine hormone-releasing system,
• Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study,
• Bilateral vasectomy of partner at least 3 months before the study;
5. Female subjects of non-childbearing potential must meet one of the following criteria:
• Absence of menstrual bleeding for 1 year prior to baseline without any other medical reason, confirmed with follicle-stimulating hormone (FSH) level in the postmenopausal range,
• Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study,
Note: Bilateral tubal ligation is not accepted as reason for non-childbearing potential;
6. 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;
7. Understand and sign an ICF before any investigational procedure(s) are performed.

For detailed information on the inclusion criteria please refer to the study protocol.
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 24
F.1.3 Elderly (>=65 y

Exclusion Criteria

Individuals meeting any of the following criteria are ineligible to participate in this study:
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. Receipt of prohibited medications, including rescue therapy, in the LTE study RD.06.SPR.202699 within 6 months of the Week 52 visit (Section 9.6.3);
4. Pregnant women (positive pregnancy test result at baseline visit), 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 Investigator’s judgment, if he/she participates in the clinical study, or may interfere with study assessments (e.g., poor venous access or needle-phobia);
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 baseline;
9. Subjects with confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 2 weeks before baseline;
10. Any condition the Investigator deems incompatible with subject participation in the study.

For detailed information on the exclusion criteria please refer to the study protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in subjects with prurigo nodularis (PN) who previously responded to treatment in the LTE study RD.06.SPR.202699.;Secondary Objective: To assess the safety of nemolizumab compared to placebo over a 24-week period in subjects with PN who previously responded to treatment in the LTE study.;Primary end point(s): Time from baseline to relapse, defined as meeting at least 1 of the following criteria: <br>• Increase in (weekly average of the) Peak Pruritus Numeric Rating Scale (PP NRS) score =4 points from baseline;<br>• Increase in Investigator Global Assessment (IGA) score =2 points from baseline.;Timepoint(s) of evaluation of this end point: Every 4 weeks ending with Week 24.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy Endpoints<br>The secondary efficacy endpoints include:<br>• Proportion of subjects with increase in PP NRS score =4 points from baseline at each scheduled visit;<br>• Proportion of subjects maintaining IGA success, defined as IGA score of 0 (clear) or 1 (almost clear) at each scheduled visit;<br>• Proportion of subjects with increase in IGA =2 points from baseline at each scheduled visit;<br>• Absolute and percent change from baseline in PP NRS at each scheduled visit;<br>• Absolute and percent change from baseline in Sleep Disturbance (SD) NRS at each scheduled visit;<br>• Change from baseline in DLQI at Week 16 and Week 24.<br><br>Safety Endpoints<br>The safety endpoints of this study are as follows:<br>• Incidence and severity of adverse events (AEs), including treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), serious AEs (SAEs), treatment-related AEs, and AEs that lead to discontinuation.;Timepoint(s) of evaluation of this end point: Throughout the study.

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