NEMOLIZUMAB for Prurigo Nodularis

Inclusion criteria

• {"criterion_text":"- Individuals must meet all of the following criteria at screening and baseline, as applicable, to be included in the study (individuals reentering from the phase 3b durability study RD.06.SPR.203890 must meet all inclusion criteria at re-entry Week R0):\n- 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 reenter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites).\n- 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. 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.\n- 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.\n- 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.\n- 5. Understand and sign an informed consent form before any investigational procedure(s) are performed."}

Exclusion criteria

• {"criterion_text":"- Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study (individuals re-entering from the phase 3b durability study RD.06.SPR.203890 meeting any of the following criteria at the re-entry Week R0 visit are ineligible): 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 7 in the protocol within the specified timeframe before the baseline or re-entry Week R0 visit; 4. Pregnant women (positive pregnancy test result at screening, 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 or re-entry Week R0 visit.\n- 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. 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 of the protocol. 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. 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 (eg, primary biliary cirrhosis), or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care; 14. History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis); 15. Subjects with active atopic dermatitis (signs and symptoms other than dry skin) in the last 3 months; 16. Neuropathic and psychogenic pruritus, such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis; 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 (including anaphylaxis) to an immunoglobulin (plasma-derived or recombinant) product (eg, monoclonal antibody) or to any of the study drug excipients; 19. Current active or latent tuberculosis (TB) infection or history of either untreated or inadequately treated active or latent TB according to the local applicable guidelines."}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of adverse events (AEs), including AEs of special interest, treatment-emergent AEs, and serious AEs.","definition_or_measurement_approach":"Incidence and severity of AEs, including AEs of special interest, treatment-emergent AEs (TEAEs), and serious AEs (SAEs); measured as occurrences and severity of reported adverse events."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890):","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Proportion of subjects with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear]) at each visit up to Week 184","definition_or_measurement_approach":"Proportion achieving IGA 0 or 1 at each visit through Week 184 (IGA defined in protocol)."}
• {"endpoint_text":"- Proportion of subjects with an improvement of ≥4 from baseline in PP NRS up to Week 184","definition_or_measurement_approach":"Proportion with ≥4-point improvement in Peak Pruritus Numeric Rating Scale (PP NRS) from baseline up to Week 184."}
• {"endpoint_text":"- Proportion of subjects with low disease activity state (ie, IGA ≤2) at each visit up to Week 184","definition_or_measurement_approach":"Proportion with IGA ≤2 at each visit up to Week 184."}
• {"endpoint_text":"- Percentage of pruriginous lesions with excoriations/crusts (PAS item 5a) at each visit up to Week 184","definition_or_measurement_approach":"Percent of prurigo lesions showing excoriations/crusts per Prurigo Activity Score (PAS) item 5a at each visit up to Week 184."}
• {"endpoint_text":"- Percentage of healed prurigo lesions (PAS item 5b) at each visit up to Week 184","definition_or_measurement_approach":"Percent of prurigo lesions scored as healed per PAS item 5b at each visit up to Week 184."}
• {"endpoint_text":"- Change from baseline in number of lesions in representative area (PAS item 4) at each visit up to Week 184","definition_or_measurement_approach":"Change from baseline in lesion count in a representative area (PAS item 4) at each visit up to Week 184."}
• {"endpoint_text":"- Proportion of subjects with PP NRS <2 up to Week 184","definition_or_measurement_approach":"Proportion with PP NRS score <2 at visits up to Week 184."}
• {"endpoint_text":"- Absolute and percent change from baseline in PP NRS up to Week 184","definition_or_measurement_approach":"Absolute and percentage change in PP NRS from baseline to visits up to Week 184."}
• {"endpoint_text":"- Proportion of subjects with AP NRS <2 up to Week 52","definition_or_measurement_approach":"Proportion with Average Pruritus (AP) NRS <2 up to Week 52."}
• {"endpoint_text":"- Proportion of subjects with an improvement of ≥4 from baseline in AP NRS up to Week 52","definition_or_measurement_approach":"Proportion achieving ≥4-point improvement in AP NRS from baseline up to Week 52."}
• {"endpoint_text":"- Absolute and percent change from baseline in AP NRS up to Week 52","definition_or_measurement_approach":"Absolute and percent change in AP NRS from baseline to Week 52."}
• {"endpoint_text":"- Proportion of subjects with an improvement of ≥4 from baseline in Sleep Disturbance (SD) NRS up to Week 184","definition_or_measurement_approach":"Proportion with ≥4-point improvement in Sleep Disturbance NRS from baseline up to Week 184."}
• {"endpoint_text":"- Absolute and percent change from baseline in SD NRS up to Week 184","definition_or_measurement_approach":"Absolute and percent change in Sleep Disturbance NRS from baseline to Week 184."}
• {"endpoint_text":"- Change from baseline in PN-associated pain frequency up to Week 184","definition_or_measurement_approach":"Change from baseline in frequency of PN-associated pain up to Week 184 (measurement per protocol)."}
• {"endpoint_text":"- Change from baseline in PN-associated pain intensity up to Week 184","definition_or_measurement_approach":"Change from baseline in intensity of PN-associated pain up to Week 184."}
• {"endpoint_text":"- Proportion of subjects reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) at each visit up to Week 52","definition_or_measurement_approach":"Proportion reporting low disease activity (per PGAD categories) at visits up to Week 52."}
• {"endpoint_text":"- Proportion of subjects satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) at each visit up to Week 52","definition_or_measurement_approach":"Proportion reporting satisfaction levels (good/very good/excellent) on PGAT at visits up to Week 52."}
• {"endpoint_text":"- Proportion of subjects with an improvement of ≥4 from baseline in Dermatology Life Quality Index (DLQI) up to Week 184","definition_or_measurement_approach":"Proportion achieving ≥4-point improvement in DLQI from baseline up to Week 184."}
• {"endpoint_text":"- Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184","definition_or_measurement_approach":"Change from baseline in EQ-5D score up to Week 184."}
• {"endpoint_text":"- Time to permanent study drug discontinuation","definition_or_measurement_approach":"Time (days) from first dose to permanent discontinuation of study drug."}
• {"endpoint_text":"- Time to rescue therapy use","definition_or_measurement_approach":"Time to first use of protocol-defined rescue therapy."}
• {"endpoint_text":"- Proportion of subjects receiving any rescue treatment by rescue treatment","definition_or_measurement_approach":"Proportion receiving rescue treatments, categorized by rescue treatment type."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with an Investigator Global Assessment (IGA) success (defined as IGA of 0 [Clear] or 1 [Almost clear]) at each visit up to Week R132 by treatment and overall [relapsed, non-relapsed subjects]","definition_or_measurement_approach":"Proportion with IGA success at visits through Week R132 in re-entered subjects, by treatment and relapse status."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with an improvement of ≥4 from re-entry baseline in Peak Pruritus numeric rating scale (PP NRS) up to Week R132 by treatment and overall [relapsed subjects]","definition_or_measurement_approach":"Proportion achieving ≥4 improvement in PP NRS from re-entry baseline to Week R132 in re-entered (relapsed) subjects."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with an improvement of ≥4 from baseline in Peak Pruritus numeric rating scale (PP NRS) up to Week R132 by treatment and overall [non-relapsed subjects]","definition_or_measurement_approach":"Proportion achieving ≥4 improvement in PP NRS from baseline to Week R132 in re-entered non-relapsed subjects."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with recapture of clinical response, defined as: Investigator Global Assessment (IGA) success and an improvement of ≥ 4 from re entry baseline in Peak Pruritus numeric rating scale (PP NRS) up to Week R132 by treatment and overall [relapsed subjects]","definition_or_measurement_approach":"Proportion meeting combined criteria (IGA success and ≥4 improvement in PP NRS from re-entry baseline) up to Week R132 in relapsed re-entered subjects."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with maintenance of clinical response, defined as: Investigator Global Assessment (IGA) success and an improvement of ≥4 from baseline in Peak Pruritus numeric rating scale (PP NRS) up to Week R132 by treatment and overall [non-relapsed subjects]","definition_or_measurement_approach":"Proportion maintaining clinical response (IGA success and ≥4 improvement in PP NRS) up to Week R132 in non-relapsed re-entered subjects."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with an improvement ≥4 from baseline in Sleep Disturbance numeric rating scale (SD NRS) up to Week R132 by treatment and overall [relapsed and non-relapsed subjects]","definition_or_measurement_approach":"Proportion with ≥4 improvement in SD NRS from baseline to Week R132 in re-entered subjects (relapsed and non-relapsed)."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Proportion of subjects with an improvement ≥4 from baseline in Dermatology Life Quality Index (DLQI) up to Week R132 by treatment and overall [relapsed and non-relapsed subjects]","definition_or_measurement_approach":"Proportion with ≥4 improvement in DLQI from baseline to Week R132 in re-entered subjects."}
• {"endpoint_text":"- For subjects who re-entered from durability study (RD.06.SPR.203890): Time to recapture of clinical response for relapsed subjects who received placebo in the durability study (RD.06.SPR.203890)","definition_or_measurement_approach":"Time to recapture of clinical response for relapsed subjects who had previously received placebo in the durability study (as defined in protocol)."}

Hungary

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

3

Spain

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

3

Belgium

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

8

Number Of Sites

3

Number Of Participants

21

Denmark

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

10

Number Of Sites

2

Number Of Participants

12

Sweden

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

9

Number Of Sites

1

Number Of Participants

2

Poland

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

10

Number Of Sites

17

Number Of Participants

103

Netherlands

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

8

Number Of Sites

2

Number Of Participants

16

Austria

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

28-10-2024

Processing Time Days

48

Number Of Sites

3

Number Of Participants

28

France

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

26-09-2024

Processing Time Days

16

Number Of Sites

9

Number Of Participants

45

Italy

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

38

Number Of Sites

9

Number Of Participants

27

Germany

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

24-09-2024

Processing Time Days

14

Number Of Sites

17

Number Of Participants

88

Primary sponsor

Full Name

Galderma S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Operational study support, sample analysis (NAB assay), PK and ADA analysis and multiple study support functions (see sponsor duties codes and values in record)

Third parties

• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Sample Analysis by NAB assay; various operational and study support roles (sponsorDuties codes: 15, 10, 11, 12, 13, 2, 3, 5, 6, 7, 8 as listed per record)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Kits and materials provider, Specimen Storage, Shipment of stored specimen to third party vendor; code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG and electronic Clinical Outcome Analysis (listed duty value)","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"PK and ADA analysis (listed duty value)","organisation_type":"Hospital/Clinic/Other health care facility"}