A Phase 3 interventional study of Nemolizumab and Placebo in Prurigo Nodularis, sponsored by Galderma R&D. Completed at 14 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Galderma R&D (part of Galderma Group AG) · Phase 3, Interventional, and Treatment
The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The secondary objective of this study is to assess the safety of nemolizumab compared to placebo over a 24-week period in participants with PN who previously responded to treatment in the LTE study.
38 studies on the registry are indexed under Prurigo; 10 are open to participants now.
This study's enrollment of 34 is below the median of 135 across 31 interventional studies indexed under Prurigo.
Browse Prurigo studies →Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants who achieved a clinical response at Week 52 of the LTE study RD.06.SPR.202699, defined as:
Female participants of non-childbearing potential must meet one of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Nemolizumab
Drug: Placebo
Participants received either 1 \[30 milligram (mg)\] or 2 (2\*30 mg) subcutaneous (SC) injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by interactive response technology (IRT).
Also known as: CD14152
Participants received either 1 (30 mg) or 2 (2\*30 mg) SC injection(s) of placebo every 4 weeks for a period of 24 weeks (with last injection at Week 20). Participants received the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by IRT.
Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria
Time from baseline to relapse, defined as meeting at least 1 of the following criteria. 1. Increase in (weekly average of the) PP NRS score \>=4 points from baseline 2. Increase in IGA score \>=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication
Time frame: Baseline up to Week 24
Percentage of Participants Maintaining Investigator Global Assessment (IGA) Success at Each Scheduled Visit
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Treatment response/success was defined as 0 (clear) or 1 (almost clear).
Time frame: Baseline up to Week 24
Percentage of Participants With Increase in Peak Pruritus (PP) Numeric Rating Scale (NRS) Score of >= 4 Points From Baseline at Each Scheduled Visit
Pruritus NRS is a scale that is used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a 11-point scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
Time frame: Baseline up to Week 24
This study was conducted at 14 study sites in 7 countries from 24 January 2022 to 11 September 2023.
| Milestone | Nemolizumab | Placebo |
|---|---|---|
| Started | 18 | 16 |
| Completed | 14 | 4 |
| Not completed | 4 | 12 |
| Withdrew: Lack of efficacy | 3 | 12 |
| Withdrew: Adverse event | 1 | 0 |
Time from baseline to relapse, defined as meeting at least 1 of the following criteria. 1. Increase in (weekly average of the) PP NRS score \>=4 points from baseline 2. Increase in IGA score \>=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication
| Days | Nemolizumab | Placebo |
|---|---|---|
| Time From Baseline to Relapse Meeting At Least 1 of the Defined Criteria | NA (NA to NA) | 112.50 (84.00 to 161.00) |
IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator reviewed the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe). Treatment response/success was defined as 0 (clear) or 1 (almost clear).
| Percentage of Participants | Nemolizumab | Placebo |
|---|---|---|
| At Week 4 | 88.2 | 86.7 |
| At Week 8 | 82.4 | 81.3 |
| At Week 12 | 88.2 | 53.3 |
| At Week 16 | 81.3 | 27.3 |
| At Week 20 | 86.7 | 57.1 |
| At Week 24 | 85.7 | 60.0 |
Pruritus NRS is a scale that is used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores are provided on a 11-point scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
| Percentage of Participants | Nemolizumab | Placebo |
|---|---|---|
| At Week 4 | 0 | 0 |
| At Week 8 | 0 | 0 |
| At Week 12 | 0 | 16.7 |
| At Week 16 | 6.7 | 33.3 |
| At Week 20 | 0 | 33.3 |
| At Week 24 | 0 | 0 |
Collected over From Baseline up to end of study (Week 32). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nemolizumab | 0/18 (0%) | 2/18 (11.1%) | 11/18 (61.1%) |
| Placebo | 0/16 (0%) | 0/16 (0%) | 10/16 (62.5%) |
| Event | Nemolizumab | Placebo |
|---|---|---|
| Clavicle fractureInjury, poisoning and procedural complications | 1/18 | 0/16 |
| ConcussionInjury, poisoning and procedural complications | 1/18 | 0/16 |
| Cerebral ischaemiaNervous system disorders | 1/18 | 0/16 |
| Event | Nemolizumab | Placebo |
|---|---|---|
| COVID-19Infections and infestations | 2/18 | 3/16 |
| HeadacheNervous system disorders | 3/18 | 1/16 |
| Upper respiratory tract infectionInfections and infestations | 0/18 | 2/16 |
| InfluenzaInfections and infestations | 2/18 | 0/16 |
| HaematomaVascular disorders | 2/18 | 0/16 |
| LeukopeniaBlood and lymphatic system disorders | 0/18 | 1/16 |
| DiarrhoeaGastrointestinal disorders | 0/18 | 1/16 |
| Irritable bowel syndromeGastrointestinal disorders | 0/18 | 1/16 |
| NasopharyngitisInfections and infestations | 1/18 | 1/16 |
| SinusitisInfections and infestations | 1/18 | 1/16 |
The intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(years) | Nemolizumab | Placebo | Total |
|---|---|---|---|
| Mean | 59.9 ± 14.06 | 59.1 ± 13.41 | 59.5 ± 13.56 |
| Sex: Female, Male(Participants) | Nemolizumab | Placebo | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 4 | 3 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Nemolizumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 13 | 15 | 28 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Race (NIH/OMB)(Participants) | Nemolizumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 15 | 29 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2022 to primary completion in Sep 2023, 19 months.
Results were first posted in Oct 2024, 1 year after primary completion.
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Studies of the drug tested here: Nemolizumab