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NCT07074977: CPUO
An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)
Phase 2 trial testing nemolizumab in Chronic Pruritus of Unknown Origin in 50 participants. Currently enrolling.
1 September 2026
Quick facts
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 20 October 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 January 2027 |
| Sites | 26 locations across United States, Canada |
Drugs / interventions tested
- nemolizumab (NEMOLIZUMAB) — full drug profile →
- Placebo
Conditions studied
- Chronic Pruritus of Unknown Origin — all drugs for Chronic Pruritus of Unknown Origin →
Sponsor
Galderma R&D — full company profile →
Who can join
18 and older, any sex, with Chronic Pruritus of Unknown Origin. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Population Pharmacokinetics (PopPK) Model of the Elimination of nemolizumab During the 16-week Treatment Period Point
Time frame: From Baseline up to Week 16
Point Estimate of Population Total Clearance (Cl/F) of nemolizumab will be reported. -
Population Pharmacokinetics (PopPK) Model of the Distribution of nemolizumab During the 16-week Treatment Period Point
Time frame: From Baseline up to Week 16
Point Estimate of Population Volume of Distribution (Vd/F) of nemolizumab will be reported. -
Population Pharmacokinetics (PopPK) Model of the Absorption of nemolizumab During the 16-week Treatment Period Point
Time frame: From Baseline up to Week 16
Point Estimate of Absorption Rate Constant (Ka) of nemolizumab will be reported. -
Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of nemolizumab Systemic Exposure on Pruritus during 16-week Treatment Period
Time frame: From Baseline up to Week 16
Point Estimate of population IC50 of nemolizumab, i.e. the drug concentration required to produce 50% of the maximal inhibition of Average Peak Pruritus, will be reported.
Sponsor's own description
The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pathogenesis and Therapeutics for Chronic Pruritus of Unknown Origin: A Systematic Review.
Akiska YM, Gandhi I, Adler R, Fayyad D, et al · · 2026 · cited 1× · PMID 41531005 · DOI 10.1111/ijd.70259
Verify or expand the search:
- PubMed search for NCT07074977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of nemolizumab
Trials testing the same drug.
- NCT05214794 — An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis · Phase 2 · completed
Other Galderma R&D trials
Trials by the same sponsor.
- NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
- NCT07344584 — A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles · NA · not yet recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07398989 — A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin · Phase 4 · completed
- NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07074977 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
- Last refreshed: 28 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07074977.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing