Trial · NCT05979831
A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome
NCT05979831, Phase 1, Phase 2, Terminated, Daiichi Sankyo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome. Trials, record NCT05979831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05979831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome
- NCT number
- NCT05979831
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Netherton Syndrome
- Interventions
- DS-2325a, Placebo
- First posted
- 2023-08-07
- Last updated
- 2026-05-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | Screening (Day 0) up to Week 45 (end of study) | An AE is any untoward medical occurrence in a patient administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) v 27.1. |
| Secondary | Pharmacokinetic Parameter Trough Concentration (Ctrough) - Main Phase | Main Phase: Week 1, 1 hour postdose, 2 hour postdose and Predose at Weeks 3, 5, 7, 9, and 11 | The Ctrough summaries include trough concentrations at the designed pre-dose time points that received a prior planned dose. |
| Secondary | Pharmacokinetic Parameter Trough Concentration (Ctrough) - Extension Phase | Extension Phase: Predose at Weeks 13, 15, 17, 19, 21, and 23 | The Ctrough summaries include trough concentrations at the designed pre-dose time points that received a prior planned dose. |
| Secondary | Median Change From Baseline in Ichthyosis Area Severity Index (IASI) Scores | Baseline up to Week 13 | The IASI assesses the intensity of the participant's erythema (IASI-Erythema) and scaling (IASI-Scaling) using a 4-point Likert scale ranging from 0 (none) to 4 (very severe). The total IASI (range 0 to 48) is determined by adding IASI-Erythema and IASI-Scaling scores. Higher scores indicate worse clinical outcome. A change from baseline is being reported and the greater the change the worse clinical outcome. |
| Secondary | Median Change From Baseline in Investigator Global Assessment (IGA) Scores | Baseline up to Week 13 | The IGA assesses a participant's erythema, scaling, inflammatory papules or plaques, oozing, and lichenification using a 5-point scale (0, clear; 1, almost clear; 2, mild; 3, moderate; 4, severe). Higher scores indicate worse clinical outcome. The change from baseline is being reported where negative values indicate an improvement in clinical outcome. |
| Secondary | Median Change From Baseline in Itch Numerical Rating Scale (NRS) Scores | Baseline up to Week 13 | The Itch NRS is a self-rated single item scale designed for assessing worst pruritus in the past 7 days. The scale utilizes an 11-point NRS, scored from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate worse clinical outcome. The change from baseline is being reported with negative values indicating an improvement in clinical outcome. |
| Secondary | Median Change From Baseline in Skindex-29 Responses | Baseline up to Week 13 | The Skindex-29 is a 29-item questionnaire that assesses the burden of the participant's skin condition on 3 scales - symptoms, social functioning and emotional well-being. The score for each scale ranges from 0 to 100. Higher scores reflect a worse quality of life. |
| Secondary | Median Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire Score | Baseline up to Week 13 | The Dermatology Life Quality Index (DLQI) is a 10-item validated questionnaire used to assess participants' perception of the impact of their skin disease on different aspects of their quality of life over the prior week. The DLQI score is the sum of the 10 item scores and ranges from 0 to 30. A high score is indicative of a poor quality of life. |
| Secondary | Number of Participants With Anti-Drug Antibodies Against DS-2325a (Interventional Part Main and Extension Phases) | Baseline up to Week 45 (end of study) | The anti-drug antibodies (ADAs) against DS-2325a was assessed as the immunogenicity endpoint. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05979831
GET https://conductscience.org/api/trials/v1/NCT05979831/registered