Trial · NCT05854784
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
NCT05854784, Phase 2, Completed, Clinuvel Pharmaceuticals Limited; results first posted 2025-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP). Trials, record NCT05854784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05854784
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
- NCT number
- NCT05854784
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Conditions
- Variegate Porphyria
- Interventions
- Afamelanotide 16 MG
- First posted
- 2023-05-11
- Last updated
- 2025-04-27
- Results first posted
- 2025-04-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Disease Severity in Patients With VP as Measured by CGIC. | From baseline to Day 168 | The higher the score, the less severe the disease. Scale ranges from +3 to -3. |
| Secondary | The Change in Disease Severity in Patients With VP as Measured by 11-point VAS IGA. | Median change from baseline to Day 168. | A lower score indicates a reduced severity of the disease.Scale ranges from 0 to 10. |
| Secondary | The Change in Disease Severity in Patients With VP as Measured by 5-point IGA. | Median change from baseline to Day 168 | A lower score indicates a reduced severity of the disease. Scale ranges from 0 to 4. |
| Secondary | The Change in Disease Severity in Patients With VP as Measured by PGIC. | Median change from baseline to Day 168 | The higher the score, the less severe the disease. Score ranges from +3 to -3. |
| Secondary | The Change in Disease Severity in Patients With VP as Measured by PGA Using VAS. | Median change from baseline to Day 168 | A lower score indicates a reduced severity of the disease. Scale ranges from 0 to 10. |
| Secondary | The Change in Number of New Skin Lesions Formed. | Median change from baseline to Day 168. | A lower number indicates a reduced severity of the disease. |
| Secondary | The Change in the Quality of Life in Patients With VP as Measured by WPAI:GH. | Median of change from baseline to Day 168 | Higher score indicates greater impairment and less productivity. Score is percentage impairment. |
| Secondary | The Change in the Quality of Life in Patients With VP as Measured by VP-derived QOLEB. | From baseline to Day 168 | Higher scores represent worse health-related quality of life. Scale ranges from 0 to 45. |
| Secondary | The Change in the Quality of Life in Patients With VP as Measured by VP QoL. | Assessed at baseline and Day 168 to reflect retrospective changes over the previous 12 months. | "Quality of life measured by the number of responses of "much better than a year ago" to the question "How would you judge the condition of your skin of your face and hands today, in comparison to the situation last year (12 months ago)?" |
| Secondary | The Change in Outdoor Light Exposure Over Time (Daily Diary) | From baseline to Day 168. | Daily diaries recording outdoor light exposure. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in Disease Severity in Patients With VP as Measured by CGIC. | From baseline to Day 168 | Scores on a scale | MEDIAN | |
| SECONDARY | The Change in Disease Severity in Patients With VP as Measured by 11-point VAS IGA. | Median change from baseline to Day 168. | Scores on a scale | MEDIAN | |
| SECONDARY | The Change in Disease Severity in Patients With VP as Measured by 5-point IGA. | Median change from baseline to Day 168 | Scores on a scale | MEDIAN | |
| SECONDARY | The Change in Disease Severity in Patients With VP as Measured by PGIC. | Median change from baseline to Day 168 | Scores on a scale | MEDIAN | |
| SECONDARY | The Change in Disease Severity in Patients With VP as Measured by PGA Using VAS. | Median change from baseline to Day 168 | Scores on a scale | MEDIAN | |
| SECONDARY | The Change in Number of New Skin Lesions Formed. | Median change from baseline to Day 168. | Lesions | MEDIAN | |
| SECONDARY | The Change in the Quality of Life in Patients With VP as Measured by WPAI:GH. | Median of change from baseline to Day 168 | Percentage of impairment time | MEDIAN | |
| SECONDARY | The Change in the Quality of Life in Patients With VP as Measured by VP-derived QOLEB. | From baseline to Day 168 | Score on a scale | MEDIAN | |
| SECONDARY | The Change in the Quality of Life in Patients With VP as Measured by VP QoL. | Assessed at baseline and Day 168 to reflect retrospective changes over the previous 12 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Change in Outdoor Light Exposure Over Time (Daily Diary) | From baseline to Day 168. | Change in number of hours of sunlight | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Disease Severity in Patients With VP as Measured by CGIC. | Afamelanotide | 2.5 | Full Range 1.0 to 3.0 | Scores on a scale | |
| The Change in Disease Severity in Patients With VP as Measured by 11-point VAS IGA. | SCENESSE® (Afamelanotide 16mg) | -3.0 | Full Range -5.0 to 0.0 | Scores on a scale | |
| The Change in Disease Severity in Patients With VP as Measured by 5-point IGA. | SCENESSE® (Afamelanotide 16mg) | -2.0 | Full Range -3.0 to 1.0 | Scores on a scale | |
| The Change in Disease Severity in Patients With VP as Measured by PGIC. | SCENESSE® (Afamelanotide 16mg) | 2.5 | Full Range 1.0 to 3.0 | Scores on a scale | |
| The Change in Disease Severity in Patients With VP as Measured by PGA Using VAS. | SCENESSE® (Afamelanotide 16mg) | -6.5 | Full Range -9.0 to -1.0 | Scores on a scale | |
| The Change in Number of New Skin Lesions Formed. | SCENESSE® (Afamelanotide 16mg) | -6.5 | Full Range -11.0 to 4.0 | Lesions | |
| The Change in the Quality of Life in Patients With VP as Measured by WPAI:GH. | SCENESSE® (Afamelanotide 16mg) | -10.00 | Full Range -80.0 to 40.0 | Percentage of impairment time | |
| The Change in the Quality of Life in Patients With VP as Measured by VP-derived QOLEB. | SCENESSE® (Afamelanotide 16mg) | -12.0 | Full Range -23.0 to -3.0 | Score on a scale | |
| The Change in the Quality of Life in Patients With VP as Measured by VP QoL. | SCENESSE® (Afamelanotide 16mg) | Baseline | 0 | Participants | |
| The Change in the Quality of Life in Patients With VP as Measured by VP QoL. | SCENESSE® (Afamelanotide 16mg) | Day 168 | 5 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SCENESSE® (Afamelanotide 16mg) | 6 | |
| Overall Study | COMPLETED | SCENESSE® (Afamelanotide 16mg) | 6 | |
| Overall Study | NOT COMPLETED | SCENESSE® (Afamelanotide 16mg) | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | General disorders | General disorders | SCENESSE® (Afamelanotide 16mg) | 4 | 6 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SCENESSE® (Afamelanotide 16mg) | 0 | 6 |
| Total, other adverse events | SCENESSE® (Afamelanotide 16mg) | 4 | 6 |
| Total, serious adverse events | SCENESSE® (Afamelanotide 16mg) | 0 | 6 |
Source ClinicalTrials.gov
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/NCT05854784
GET https://conductscience.org/api/trials/v1/NCT05854784/registered