Trial · NCT05591222
Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
NCT05591222, Phase 2, Terminated, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus. Trials, record NCT05591222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05591222
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
- NCT number
- NCT05591222
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Discoid Lupus Erythematosus
- Interventions
- Placebo, Daxdilimab
- First posted
- 2022-10-24
- Last updated
- 2026-05-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24 | Baseline to Week 24 | |
| Secondary | Percentage of Participants who Achieve 0 or 1 on the Cutaneous Lupus Activity-investigator's Global Assessment (CLA-IGA) scale at Week 24 | Week 24 | CLA-IGA will be assessed by 5-point Likert Scale (0-4). |
| Secondary | Percentage of Participants who Achieve a ≥ 50% Reduction in CLASI-A Score from Baseline at Week 24 | Baseline to Week 24 | |
| Secondary | Mean Change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline to Week 24 | Baseline to Week 24 | |
| Secondary | Serum Concentration of Daxdilimab Over Time | Day 1 to Week 24 | |
| Secondary | Percentage of Participants who Develop Anti-Drug Antibodies (ADA) | Day 1 to Week 32 | |
| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Day 1 to SFU2 (Week 32) | AEs, Serious AEs (SAEs) and AEs of Special Interest (AESIs) will be monitored. An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 1. Results in death 2. Is life-threatening. An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. An AESI may be serious or nonserious. |
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/NCT05591222
GET https://conductscience.org/api/trials/v1/NCT05591222/registered