Authorised Therapeutic confirmatory (Phase III) Atopic Dermatitis

Long-term study to assess the safety and efficacy of Nemolizumab in subjects with Atopic Dermatitis

EU CTIS ID: 2024-514404-13-00

What this study is testing

The primary objective is to assess the long-term safety of Nemolizumab (CD14152) in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD).

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Adolescent subjects (aged 12-17) who have not participated in a previous nemolizumab study (selected countries/selected sites – See Appendix 3) or subjects who may benefit from study participation* in the opinion of the investigator and had participated in a prior nemolizumab study for AD including: a. Subjects who completed the initial treatment period (Week 16 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169) and do not qualify for the maintenance period; OR b. Subjects who completed the maintenance period (Week 48 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169); OR c. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 vaccination safety study (SPR.118380); OR d. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 adolescent PK/safety study (SPR.116912); OR e. Subjects who completed the treatment period (Week 24 visit) in the Phase 2b dose-ranging study (SPR.114322) and remain insufficiently controlled on topical therapy alone; OR f. Subjects who discontinued study medication in a prior study and completed required study visits prior to LTE participation (Week 16 visit for SPR.118161 and SPR.118169 initial treatment period, Week 32 visit for SPR.118161 and SPR.118169 maintenance period; final study visits for SPR.118380 [Week 16], SPR.116912 [Week 16], SPR.114322 [Week 24], SPR.201591 [Week 16], and SPR.201593 [Week 13] unless the subject experienced an AE that may present an unreasonable risk if study medication is continued; OR g. Subjects who completed the treatment period (Week 16) in the Phase 3b study (SPR.201591); OR h. Subjects who completed the treatment period (Week 13) in the Phase 2 DDI study (SPR.201593). *In Germany only, subjects who may benefit from study participation are those who experienced at least 10% reduction in EASI or at least 1-point reduction in IGA score from baseline at the last visit in the prior nemolizumab study. Note(s): For ongoing studies, transfer into the LTE study should occur as soon as possible to minimize gaps in study medication dosing. Subjects who satisfy inclusion criteria 1a through 1c are permitted to enroll immediately into the LTE study, provided other eligibility criteria are met. Enrollment of subjects aged 12 to 17 years has been open after the IDMC has assessed interim safety data from the phase 2 study (SPR.116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study. The sponsor sent a written communication to study sites confirming that the study is open for enrollment of adolescents. Adolescents could not be enrolled in the study until such communication was received.
10. AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits. Note: BSA to be derived from the SCORAD
11. SCORAD pruritus VAS score of at least 4.0 at the screening and baseline visit. SCORAD pruritus VAS is completed by the subject as a single assessment of their average pruritus symptoms over the past 3 days or nights on a scale from 0 to 10.
12. Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI).
2. Agree to apply a moisturizer at least once daily throughout the study and agree to apply the authorized topical therapy, as determined appropriate by the investigator.
3. Women of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. This criterion also applies to a prepubertal female subject who begins menses during the study. In Germany only, if a subject has reached Tanner stage 3 breast development, even if not having menarche, the subject will be considered a female of child bearing potential. Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below: • Progestogen-only oral hormonal contraception • Combination of male condom with cap, diaphragm, or sponge with spermicide (double barrier methods)* Note: “Double barrier methods” refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (e.g., condom) together with a spermicide is not acceptable. *In Germany only, double-barrier methods are not considered an adequate and approved method of contraception. • 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

You likely can't join if

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. In Czech Republic only, 1 is revised: 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. Subjects who experienced • worsening or recurrence of asthma • recurrent or severe infections during the lead-in study where continued exposure to study drug would pose unacceptable risk to the subject.
10. 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 8.3.5.2. Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this study.
11. Positive serology results (hepatitis B surface antigen [HbsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody) at the screening visit.
12. Subjects who, after a full treatment course of 16 weeks with dupilumab, experienced worsening of their AD or failed to achieve minimal improvement (eg, ≤ 10% reduction in EASI or no reduction in IGA).
13. 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 carcinoma 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.
14. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients.

See the full eligibility criteria

Who can join

1. Adolescent subjects (aged 12-17) who have not participated in a previous nemolizumab study (selected countries/selected sites – See Appendix 3) or subjects who may benefit from study participation* in the opinion of the investigator and had participated in a prior nemolizumab study for AD including: a. Subjects who completed the initial treatment period (Week 16 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169) and do not qualify for the maintenance period; OR b. Subjects who completed the maintenance period (Week 48 visit) in a Phase 3 pivotal study (SPR.118161 or SPR.118169); OR c. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 vaccination safety study (SPR.118380); OR d. Subjects who completed the treatment period (Week 16 visit) in the Phase 2 adolescent PK/safety study (SPR.116912); OR e. Subjects who completed the treatment period (Week 24 visit) in the Phase 2b dose-ranging study (SPR.114322) and remain insufficiently controlled on topical therapy alone; OR f. Subjects who discontinued study medication in a prior study and completed required study visits prior to LTE participation (Week 16 visit for SPR.118161 and SPR.118169 initial treatment period, Week 32 visit for SPR.118161 and SPR.118169 maintenance period; final study visits for SPR.118380 [Week 16], SPR.116912 [Week 16], SPR.114322 [Week 24], SPR.201591 [Week 16], and SPR.201593 [Week 13] unless the subject experienced an AE that may present an unreasonable risk if study medication is continued; OR g. Subjects who completed the treatment period (Week 16) in the Phase 3b study (SPR.201591); OR h. Subjects who completed the treatment period (Week 13) in the Phase 2 DDI study (SPR.201593). *In Germany only, subjects who may benefit from study participation are those who experienced at least 10% reduction in EASI or at least 1-point reduction in IGA score from baseline at the last visit in the prior nemolizumab study. Note(s): For ongoing studies, transfer into the LTE study should occur as soon as possible to minimize gaps in study medication dosing. Subjects who satisfy inclusion criteria 1a through 1c are permitted to enroll immediately into the LTE study, provided other eligibility criteria are met. Enrollment of subjects aged 12 to 17 years has been open after the IDMC has assessed interim safety data from the phase 2 study (SPR.116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study. The sponsor sent a written communication to study sites confirming that the study is open for enrollment of adolescents. Adolescents could not be enrolled in the study until such communication was received.
10. AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits. Note: BSA to be derived from the SCORAD
11. SCORAD pruritus VAS score of at least 4.0 at the screening and baseline visit. SCORAD pruritus VAS is completed by the subject as a single assessment of their average pruritus symptoms over the past 3 days or nights on a scale from 0 to 10.
12. Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI).
2. Agree to apply a moisturizer at least once daily throughout the study and agree to apply the authorized topical therapy, as determined appropriate by the investigator.
3. Women of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. This criterion also applies to a prepubertal female subject who begins menses during the study. In Germany only, if a subject has reached Tanner stage 3 breast development, even if not having menarche, the subject will be considered a female of child bearing potential. Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below: • Progestogen-only oral hormonal contraception • Combination of male condom with cap, diaphragm, or sponge with spermicide (double barrier methods)* Note: “Double barrier methods” refers to simultaneous use of a physical barrier by each partner. Use of a single barrier method (e.g., condom) together with a spermicide is not acceptable. *In Germany only, double-barrier methods are not considered an adequate and approved method of contraception. • 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
4. 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 • Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before screening NOTE: bilateral tubal ligation is not accepted as a reason for non-childbearing potential.
5. Subject (and guardian, when applicable) willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.
6. Understand and sign an informed consent form (and assent form, when applicable), before any investigational procedure(s) being performed. Additional Inclusion Criteria: For adolescent subjects (age 12-17) who have not participated in a previous clinical study with nemolizumab only (selected countries/selected sites).
7. Chronic AD for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria at the time of the screening visit.
8. EASI score ≥ 16 at both the screening and baseline visits.
9. IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.

What rules you out

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. In Czech Republic only, 1 is revised: 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. Subjects who experienced • worsening or recurrence of asthma • recurrent or severe infections during the lead-in study where continued exposure to study drug would pose unacceptable risk to the subject.
10. 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 8.3.5.2. Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this study.
11. Positive serology results (hepatitis B surface antigen [HbsAg] or hepatitis B core antibody [HbcAb], hepatitis C [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody) at the screening visit.
12. Subjects who, after a full treatment course of 16 weeks with dupilumab, experienced worsening of their AD or failed to achieve minimal improvement (eg, ≤ 10% reduction in EASI or no reduction in IGA).
13. 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 carcinoma 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.
14. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients.
15. History of intolerance to TCS or for whom TCS is not advisable (eg, hypersensitivity to TCS, significant skin atrophy, etc), unless TCS was not used as background therapy in the lead-in study, if applicable.
16. Known active or untreated latent tuberculosis infection.
17. Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
18. Presence of confounding skin condition that may interfere with study assessments (eg, Netherton Syndrome, psoriasis, cutaneous T-cell lymphoma [Mycosis Fungoides or Sezary Syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
19. Any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (> 3 × upper limit of normal) in combination with elevated bilirubin (> 2 × upper limit of normal), 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.
2. Having received any of the treatments in Table 10 within the specified timeframe before the baseline visit.
20. Currently participating or participated in any other study of a drug or device within the past 8 weeks before the screening visit (or 5 half-lives of the investigational drug, whichever is longer), or is in an exclusion period (if verifiable) from a previous study, other than the nemolizumab for AD studies (SPR.114322, SPR.116912, SPR.118380, SPR.118169, SPR.118161, SPR.201591, and SPR.201593).
21. History of alcohol or substance abuse within 6 months of the screening visit.
3. Pregnant women (positive pregnancy test result at screening or baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
4. Any medical or psychological condition at the screening visit 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).
5. Planning or expected to have a major surgical procedure during the clinical study.
6. Subjects unwilling to refrain from using prohibited medications during the clinical study.
Additional Exclusion Criteria: For new adolescent subjects or for subjects who do not rollover from a prior nemolizumab study within 28 days of completing final study assessments during the lead-in study: 7. Body weight < 30 kg. In Czech Republic only, 7 applies to all subjects.
8. Subjects meeting 1 or more of the following criteria at screening or baseline: 8a. Had an asthma exacerbation requiring hospitalization in the preceding 12 months; 8b. Reporting asthma that has been not 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; 8c. Asthma Control Test (ACT) ≤ 19 (only for subjects with a history of asthma); 8d. Peak expiratory flow < 80% of the predicted value. Note: In the event that PEF is  80% of the predicted value at the screening visit, PEF testing can be repeated once within 48 hours: • For subjects without a history of asthma • For subjects with a history of asthma but if the ACT score is >19 at screening.
9. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.

The study team makes the final eligibility decision.

Where it's taking place

Singapore
United Kingdom
Korea, Republic of
Canada
Australia
United States
New Zealand
Georgia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Singapore; United Kingdom; Korea, Republic of; Canada; Australia; United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.