A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
- Conditions
- Itching of the skin10014982
- Registration Number
- NL-OMON54290
- Lead Sponsor
- Galderma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
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 in a phase 3 pivotal study
(RD.06.SPR.202685 or RD.06.SPR.203065) and enroll within 56 days
OR
b. Subjects who were previously randomized in the nemolizumab phase 2a PN study
(RD.03.SPR.115828).
OR
c. Subjects who completed through Week 24 of the phase 3b durability study
(RD.06.SPR.203890) or who exit the study due to relapse may be eligible to
re-enter in the LTE study within 28 days of exiting the durability study
(selected countries/ selected sites)
Note: Transfer into the LTE study from a phase 3 study can occur immediately
but must occur within 56 days of lead-in study completion, provided other
eligibility criteria are met. Subjects from the phase 2 study, subjects who
rollover between 29 to 56 days after completion of a phase 3 study, or subjects
who discontinued study drug but otherwise completed a phase 3 study must
undergo a separate screening visit prior to the baseline visit. Subjects from a
phase 3 study who do not rollover within 56 days are ineligible for
participation in the LTE.
2. Female subjects of childbearing potential (ie, fertile, following menarche
and until becoming post-menopausal 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. See Appendix 1 for details. 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) (*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 (eg, condom) together 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
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, confirmed with follicle stimulating hormone (FSH) level in the
postmenopausal range
OR
• Documented hysterectomy, bilateral salpingectomy, 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 us
Exclusion Criteria:
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 following treatments in Table 3 within the
specified timeframe before the baseline visit or re-entry Week R0 visit
4. Pregnant women (positive pregnancy test result at screening or baseline or
re-entry Week R0 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
(eg, 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 the screening visit
or re-entry Week R0 visit.
For subjects who do not rollover within 28 days from a prior nemolizumab study
or who completed study visits but prematurely discontinued study drug, the
following exclusion criteria also apply:
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 (ie, symptoms occurring
on >2 days per week, nighttime awakenings 2 or more times per week, or some
interference with normal activities) during the preceding 3 months.
c. Asthma Control Test (ACT) <=19 (only for subjects with a history of asthma)
at screening and baseline.
d. Peak expiratory flow (PEF) <80% of the predicted value.
Note: In the event that PEF is <80% of the predicted value at screening in
patients without any history of asthma or in patients with history of asthma
but with the ACT score >19, PEF testing can be repeated once within 48 hours.
10. Subjects with a current medical history of chronic obstructive pulmonary
disease and/or chronic bronchitis.
11. Cutaneous infection within 1 week before the baseline visit, any infection
requiring treatment with oral or parenteral antibiotics, antivirals,
antiparasitics or antifungals within 2 weeks before the baseline visit, or any
confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks
before the screening or baseline visit. Subjects may be rescreened once the
infection has resolved. Resolution of COVID-19 infection can be confirmed by
recovery assessment methods, as described in Section 8.4.2.
12. Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis
B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory
test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency
virus antibody) at screening.
Note: Subjects with a positive HBcAb and a negative HBsAg can be included in
this clinical study if hepatitis B surface antibody is positive (considered
immune after a natural infection). Subjects with negative confirmatory test for
HCV can be included in this clinica
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>• Incidence and severity of adverse events (AEs), including AEs of special<br /><br>interest, treatment-emergent AEs, and serious AEs. </p><br>
- Secondary Outcome Measures
Name Time Method